Stroke Thrombolysis Guideline Extended Age and Treatment Window

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STROKE THROMBOLYSIS GUIDELINE VERSION 7

1. Aim/Purpose of this Guideline To deliver safe and effective thrombolysis for acute ischaemic stroke using robust evidence based clinical criteria.

2. The Guidance

Contents Page Reason for change 2

Thrombolysis pathway 3 Clinical Exclusions from thrombolysis 5

Management of hypertension 7 r-tPA dose ready reckoner 8

Consent issues 9 Management of complications after thrombolysis 10

NIH Stroke Scale (full version) 11 Nursing protocol and care plan 18

Short NIHSS score sheet 21 Peninsula Heart & Stroke Network Clinical Reference Group

statement on thrombolysis 22

Education and References 24 Monitoring and Effectiveness and compliance 25

Governance information 26 Equality Impact Assessment 28

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Referral of Patients with Acute Stroke and Proximal Artery Occlusion for Consideration of Intra-arterial Treatment at Derriford Hospital Intravenous thrombolysis has been offered at RCHT since 2008 and the evidence shows that it

improves outcome in patients following ischaemic stroke [1]. There is now evidence also for

mechanical thrombectomy and the inclusion criteria are listed below with discussing evidence for

the procedure on page [2-8]. Early thrombectomy with second-generation stent retriever devices is

safe and effective for reducing disability when used to treat patients with stroke caused by proximal

large artery occlusions. The NNT for one additional person to achieve functional independence in

these trials was 2.6.

Referrals only accepted between the hours of 09:00 and 15:00 Monday to Friday. Please consider following patients for referral for intra-arterial treatment:

Ischaemic stroke patient-if no improvement within 30 minutes of intravenous

thrombolysis on NIHSS

Demonstration of proximal vessel occlusion CT angiogram (terminal ICA, M1,

proximal M2, basilar), considered responsible for the patient’s presentation

Possibility of clot extraction within 4.5 hours of stroke (time to groin puncture 4

hours).

Exclusion criteria

Any evidence of haemorrhagic transformation (or primary haemorrhage)

Age greater than 80

Hypodensity involving more than 1/3 of middle cerebral artery territory

Significant comorbidities that reduce the likelihood of a good clinical outcome

Opinion of receiving clinician that clot extraction will be impossible in the required time

How to proceed:

ED consultant discusses patient with stroke consultant on Phoenix (ext 2120/via

switch)

ED consultant in charge of patients care requests urgent CT angiogram

Stroke consultant contacts on call interventional neuroradiology consultant at

Derriford hospital (mobile 07659589585 or phone 01752 431383).

Large bore iv access and urgent transfer of patient by radiographers (main CT

scanner)

Patient accompanied to scanner by ED nurse (stroke nurse when available)

Images are uploaded PACS as soon as obtained

ED consultant contacts Derriford neuroradiology team once CTA images uploaded

and arranges urgent transfer to Derriford hospital.

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Derriford Hospital # 6171 request the stroke registrar (1908) to arrange bed and transfer

PRE-HOSPITAL Stroke eligible for thrombolysis:

Positive FAST (Face, Arm and Speech Test)

Age 18 or older

Symptoms noted on waking exclude thrombolysis (unless last awake within thrombolysis window)

Symptom onset to thrombolysis within 6h

No seizure at onset

Check BM, confirm time of onset, transport to ED RCHT, with NOK and list of pills if available. Pre-alert ED – ensure name, DOB and AFFECTED SIDE included

EMERGENCY DEPARTMENT

Book CT on MAXIMS – ensure side affected is clear on request

Ring 4444 to alert radiographer/stroke nurse/stroke ward

Transport patient straight to CT on arrival for urgent CT head

Brief medical history to confirm time of onset, inclusion and exclusion criteria

Perform NIHSS examination (National Institute Health Stroke Scale)

Brief general examination, estimate weight

BP both arms, repeat higher arm BP after 15 minutes (manual cuff not dynamap)

Manage high BP as per protocol

iv access x2

Urgent bloods = FBC, U&E, clotting, G&S (INR if on warfarin), lipids, glucose

ECG (and CXR if needed)

DVT clinic staff will do point of care INR if on warfarin

If inpatient stroke ring red phone in ED 2153 and transfer patient to ED for CT scan and assessment, discuss with ED consultant and radiographer

RCHT STROKE THROMBOLYSIS PATHWAY

CT SCANNER Radiographer performs scan and informs on call radiologist to report scan

Report should be available within 30 minutes of scan

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DECISION TO THROMBOLYSE Repeat NIHSS to ensure not rapidly improving

Do not delay while waiting for bloods (unless on warfarin or on chemo or known haematological disorder)

Decision to thrombolyse taken by thrombolysing doctor

Obtain verbal consent if possible

Calculate dose using ready reckoner, give bolus in 10ml syringe over 1-2 minutes then infusion over 1 hour using 50ml syringe driver

Start treatment in ED and organise bed on Hyperacute stroke unit (Phoenix ward), hand over patient to stroke consultant in hours or medical registrar out of hours

If no bed available on acute stroke unit contact site coordinator, refer patient to ITU consultant and ITU nurse and transfer to ITU for 12 hours of monitoring

If no acute stroke nurse available for 1:2 care transfer patient to ITU (as above)

If large vessel occlusion suspected (NIHSS >9) please consider referral for intra-arterial treatment and CTA (see first page of guidance)

MONITOR FOR COMPLICATIONS Watch for signs of neurological deterioration, bleeding, anaphylaxis

Repeat NIHSS at 30 minutes

Manual BP, pulse, GCS, respiratory rate, temperature, SaO2 every 15 min for 2h, then every 30 min for 6 h, then every hour for 18h

Maintain BP Systolic <180 and Diastolic <105, Temperature < 37°C.

Avoid urinary catheter, nasogastric tube, intramuscular injections for first 24h

Avoid antiplatelets / anticoagulants until repeat CT at 24h excludes bleeding

Do not anticoagulate for Atrial fibrillation in first 24 hours after lysis

Inform medical registrar of any concerns

Manage complications as per protocol (page 10)

Prescribe Intermittent compression stockings for VTE prophylaxis

AT 30 min If no improvement consider please consider referral for intra-arterial treatment

and CTA (see first page of guidance)

AT 24 HOURS Repeat routine CT scan and repeat NIHSS at 24h

Start antiplatelet treatment as per protocol if no bleeding on repeat CT

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CLINICAL EXCLUSIONS FROM THROMBOLYSIS Do not give thrombolysis if you have ticked any ‘YES’ boxes

YES NO

FROM THE HISTORY

Time of onset unknown

Awoke with symptoms, unless last awake within lysis window

Seizure at onset

Known bleeding diathesis

Arterial puncture at a non-compressible site, or lumbar puncture, within the last 7 days

Major surgery within the last 14 days

Gastrointestinal or urinary tract haemorrhage within 21 days

Head injury, intracranial surgery or stroke within the last 3 months

Any history of intracranial haemorrhage, brain tumour, intracranial AVM or aneurysm

TIME OF ONSET Within 3h – no upper age limit

3 to 4.5h – can treat if 18-80y, patients over 80y do not benefit 4.5 to 6h – patients 18-80 may benefit – needs decision by thrombolysing doctor

ANTICOAGULANTS Current warfarin treatment is not exclusion if the INR is 1.7 or less.

Current heparin treatment is not an exclusion if the APTT ratio is less than 1.2

Full dose (but not low dose/prophylactic) LMWH is an exclusion Rivaroxaban/Dabigatran – if a patient is on these treatments, 24h or 12h respectively

should elapse before thrombolysis considered. This excludes these patients from thrombolysis for stroke.

PREGNANCY Pregnancy or women who are post-partum – r-tPa is unlicensed for use in pregnancy.

It should not be withheld in pregnant patients with ischaemic stroke, but because experience is limited, risks and benefits must be carefully weighed and should be

discussed with on-call obstetrician

CHEMOTHERAPY Some chemotherapy agents may be relative contra-indications to thrombolysis or

patients may be thrombocytopaenic. If patient on chemotherapy drugs please ensure bloods normal first and check with oncology or haematology before giving lysis

CHILDREN

Alteplase is not licensed for <18y. Studies are ongoing in children. Cases should be discussed by paediatric team with paediatric neurologists at Bristol urgently.

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ON INITIAL ASSESSMENT

YES NO

Coma (GCS <8; NIH-SS question 1a = 3)

Minor stroke symptoms Sensory symptoms only

Dysarthria only

Ataxia only

Minimal weakness not registering on NIHSS

Partial visual field defect only

Clinical presentation suggestive of subarachnoid haemorrhage (even if subsequent CT normal)

DBP>140 or BP>180/105 having received more than 2 doses labetolol (see management of hypertension page 7)

Capillary glucose <2.7 (Treat as per Trust protocol)

YES NO

ON LAB RESULTS

Platelets <100 (only wait for FBC if known haematological disorder or on chemo)

Current warfarin treatment with INR MORE THAN 1.7 Do not start treatment until INR available

Current heparin treatment and APTT > 1.2 Do not start treatment until APTT available

Current treatment with full dose LMWH

Plasma glucose <2.7 (Treat as per Trust protocol)

ON CT SCAN – reported by radiologist

Radiological signs of intracranial haemorrhage

Diffuse swelling of a cerebral hemisphere

CONFIRM PATIENT ELIGIBLE FOR THROMBOLYSIS YES NO

VERBAL CONSENT? YES NO

SIGNATURE

NAME DATE TIME

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MANAGEMENT OF HYPERTENSION IN POTENTIAL THROMBOLYSIS PATIENTS

Record BP in both arms using Manual cuff Use arm with highest BP reading thereafter

Repeat after 15 minutes if hypertensive

Blood Pressure < 180

Systolic <105 Diastolic

Monitor BP, do not intervene, Thrombolyse if eligible

Systolic > 220 mmHg

And / Or Diastolic 121-140 mmHg

*Give IV Labetalol 10 iv over 1-2 minutes Repeat same or double dose to bring BP down to 180/105

Or Labetalol Infusion 2-8mg/min

Systolic >180

And/or Diastolic >105 mmHg

*Give IV Labetalol 10 iv over 1-2 minutes Repeat same or double dose to bring BP down to 180/105

Or Labetalol Infusion 2-8mg/min

If Diastolic above 140

mmHg

patient NOT eligible for Thrombolysis

*If more than 2 doses of labetolol needed Patient NOT eligible for Thrombolysis

In asthma, cardiac failure or 1st degree heart block use Isoket infusion (2-10mg /hr)

Monitoring of BP after Thrombolysis Blood Pressure after Thrombolysis should be measured

Every 15 minutes for 2 hours Every 30 minutes for 6 hours

Hourly for 18 hours During Thrombolysis and afterwards BP should be managed to below 180/105 using the above instructions – If Blood pressure rises sharply during or after Thrombolysis suspect

Intracranial haemorrhage.

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RtPA DOSE READY RECKONER Alteplase, Recombinant tissue plasminogen activator (Actilyse® Boehringer Ingelheim)

Unless the patient or companion knows their recent weight, estimate it to the nearest 5 kg

The total dose of rt-PA is 0.9 mg/kg or 90 mg, whichever is the lesser (Column 5)

Make up one or two vials of rt-PA using the 50 ml diluent in each drug pack, making a solution of 1 mg/ml rt-PA

Draw up and give 10% as a bolus over 1-2 minutes (Column 3), using a 10 ml syringe

Draw up the remaining 90% (the ‘infusion dose’, Column 4) into 1 or 2, 50ml syringes and set up the 50ml syringe driver (IVAC) with the corresponding infusion rate in mls/hr. This infusion is given over 1h.

Do not give the cardiac dose

Do not give more than 90 mg

1 2 3 4 5

Estimate of

patients weight (kg)

Equivalent Imperial weight

Bolus dose (mls)

given over 1-2 minutes

Infusion dose (mls) = infusion rate

in mls/hr

Total dose (mg at 1 mg/ml)

One vial

45 7 st 1 lb 4 36 40

50 7 st 12 lb 5 40 45

55 8 st 9 lb 5 44 49

Two vials

60 9 st 6 lb 5 49 54

65 10 st 3 lb 6 52 58

70 11 st 0 lb 6 57 63

75 11 st 11 lb 7 60 67

80 12 st 8 lb 7 65 72

85 13 st 5 lb 7 69 76

90 14 st 2 lb 8 73 81

95 14 st 13 lb 8 77 85

≥100 15 st 10 lb 9 81 90

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ISSUES AROUND CONSENT Information for patients / relatives before giving thrombolysis Thrombolysis with r-tPA is a licensed treatment for acute ischaemic stroke, and written

consent is not required. If possible there should be agreement from the patient and / or

relative.

When the patient cannot agree because of their impairments and no relative is available,

then treatment can still be given if it is judged to be in the best interests of the patient. Any

explanation might include:

There has been a significant stroke caused by a blocked artery preventing blood

from getting to a part of the brain and causing permanent damage. With or without

treatment there may be some recovery or things could get worse. Stroke is fatal in

about a third of people.

Only one treatment has been shown to prevent damage to the brain. This treatment

dissolves the blood clot blocking the artery and allows blood to get back to the brain.

It only works if given quickly after the stroke starting and the benefit is greater the

sooner it is given

There is a slight increased risk of death within the first week (8.9 vs 6.4%), mostly

due to fatal intracranial bleeding (3.6 vs 0.6%). But after the first week there is a

lower chance of death (11.5 vs 13.6%), so several months later there is no

difference in chance of death overall.

The chances of being alive and independent (Rankin score 0-2) several months later

are higher,

% chance of being alive and

independent at 3 months if lysed

% chance of being alive and independent at 3 months if not

lysed

Absolute benefit – number of extra

patients alive and independent at 3 months per 1000 patients treated

if treated within 3h 40.7% 31.7% 90

If treated 3-6h 47.5% 45.7% 18

if treated within 6h 46.3% 42.1% 42

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MANAGEMENT OF COMPLICATIONS AFTER THROMBOLYSIS BP commonly drops after initiation of thrombolysis, not necessarily due to bleeding. If this happens give iv fluid bolus. Bleeding, by process of de-fibrination, is more common than with heparin (around 3%) Intracranial bleeding Should be suspected if there is neurological deterioration, new headache, fall in conscious level, acute hypertension, seizure, nausea or vomiting Initial action Stop infusion of r-tPA, repeat NIHSS, commence iv saline if needed Arrange urgent CT scan Check FBC, full coagulation screen, check blood sent for G&S If CT scan shows bleeding

Is haemorrhage petechial? If so it is unlikely anything other than stopping r-tPA will be needed. Continue to observe patient closely

Is haemorrhage parenchymal? Give 20% mannitol 200ml stat (dose may be repeated) Consider tranexamic acid 10 mg iv and 10 units cryoprecipitate Further advice is available via the intranet anti-coagulation guidelines

Consult neurosurgeon regarding possible transfer for haematoma evacuation If CT scan shows no bleeding Recheck patient for other causes of deterioration eg recurrent ischaemic stroke, sepsis, seizure, metabolic derangement, extracranial bleeding Extracranial bleeding Should be suspected if there is shock, drop in BP, evidence of blood loss – although a high index of suspicion is needed as blood loss may not be obvious. Initial action Stop infusion of r-tPA Check FBC, full coagulation screen, check blood sent for G&S and/or arrange cross match depending on situation Commence iv saline or blood transfusion depending on situation If patient fails to respond to simple measures or there is severe haemorrhage, consider tranexamic acid 10 mg/kg iv and 10 units cryoprecipitate Further advice is available from intranet, on call geriatrician and haematologist as above. Anaphylaxis Anaphylactic reactions to r-tPA can occur but are rare. If an urticarial rash, peri-orbital swelling or tongue swelling occur, the r-tPA should be stopped and the patient reviewed by a doctor urgently.

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NIH STROKE SCALE – full version and master copy – please record patient scores on quick version

(see page 23)

INSTRUCTION SCALE DEFINITION SCORE

1 SCORE

2

1a. Level of Consciousness: The investigator must choose a response,

even if a full evaluation is prevented by such obstacles as an endotracheal tube,

language barrier, orotracheal trauma/ bandages. A 3 is scored only if the patient makes no movement (other than reflexive

posturing) in response to noxious stimulation.

0 = Alert; keenly responsive. 1 = Not alert, but rousable by minor

stimulation to obey, answer, or respond. 2 = Not alert, requires repeated

stimulation to attend, or is obtunded and requires strong or painful stimulation to

make movements (not stereotyped). 3 = Coma; Responds only with reflex motor or autonomic effects, or totally

unresponsive, flaccid, areflexic.

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1b. LOC Questions: The patient is asked the month and his/her age. The answer must be correct - there is no partial credit for being close. Aphasic

and stuporous patients who do not comprehend the questions will score 2.

Patients unable to speak because of endotracheal intubation, orotracheal

trauma, severe dysarthria from any cause, language barrier or any other problem not secondary to aphasia are scored 1. It is important that only the initial answer be

graded and that the examiner not “help” the patient with verbal or non-verbal cues.

0 = Answers both questions correctly. 1 = Answers one question correctly.

2 = Answers neither question correctly.

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1c. LOC Commands: The patient is asked to open and close the

eyes and then to grip and release the nonparetic hand. Substitute another one

step command if the hands cannot be used. Credit is given if an unequivocal attempt is made but not completed due to weakness.

If the patient does not respond to command, the task should be demonstrated

to them (pantomime) and score the result (i.e., follows none, one, or two commands). Patients with trauma, amputation, or other

physical impediments should be given suitable one-step commands. Only the first

attempt is scored.

0 = Performs both tasks correctly. 1 = Performs one task correctly.

2 = Performs neither task correctly.

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2. Best Gaze: Only horizontal eye movements will be

tested. Voluntary or reflexive (oculocephalic) eye movements will be

scored but caloric testing is not done. If the patient has a conjugate deviation of the

eyes that can be overcome by voluntary or reflexive activity, the score will be 1. If a patient has an isolated peripheral nerve

paresis (CN III, IV, OR VI) score a 1. Gaze is testable in all aphasic patients. Patients with ocular trauma, bandages, preexisting blindness or other disorder of visual acuity

or fields should be tested with reflexive movements and a choice made by the

0 = Normal 1 = Partial gaze palsy. This score is

given when gaze is abnormal in one or both eyes, but where forced deviation or

total gaze paresis are not present. 2 = Forced deviation, or total gaze

paresis not overcome by the oculocephalic manoeuvre

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investigator. Establishing eye contact and then moving about the patient from side to

side will occasionally clarify the presence of a gaze palsy.

3. Visual: Visual fields (upper and lower quadrants) are tested by confrontation, using finger counting or visual threat as appropriate. Patient must be encouraged, but if they

look at the side of the moving fingers appropriately, this can be scored as normal.

If there is unilateral blindness or enucleation, visual fields in the remaining eye are scored. Score 1 only if a clear-cut asymmetry, including quadrantanopia is found. If patient is blind from any cause

score 3. Double simultaneous stimulation is performed at this point. If there is

extinction patient receives a 1 and the results are used to answer question 11.

0 = No visual loss. 1 = Partial hemianopia.

2 = Complete hemianopia. 3 = Bilateral hemianopia (blind including

cortical blindness).

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4. Facial Palsy: Ask, or use pantomime to encourage the patient to show teeth or raise eyebrows or close eyes. Score symmetry of grimace in response to noxious stimuli in the poorly

responsive or non-comprehending patient. If facial trauma/bandages, orotracheal tube, tape, or other physical barrier obscures the face, these should be removed to the extent

possible.

0 = Normal symmetrical movement. 1 = Minor paralysis (flattened nasolabial

fold, asymmetry on smiling). 2 = Partial paralysis (total or near total

paralysis of lower face). 3 = Complete paralysis (absence of facial

movement in the upper and lower face).

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5-8. Motor Arm and Leg: The limb is placed in the appropriate

position: extend the arms 90 degrees (if sitting) or 45 degrees (if supine) and the leg 30 degrees (always tested supine). Drift is scored if the arm falls before 10 seconds or

the leg before 5 seconds. The aphasic patient is encouraged using urgency in the

voice and pantomime but not noxious stimulation. Each limb is tested in turn,

beginning with the nonparetic arm. Only in the case of amputation or joint fusion at the shoulder or hip may the score be “9” and

the examiner must clearly write the explanation for scoring as a “9”.

Arm 0 = No drift, arm holds 90 (or 45) degrees

for full 10 seconds. 1 = Drift, arm holds 90 (45) degrees, but drifts down before full 10 seconds; does

not hit bed or other support. 2 = Some effort against gravity, limb

cannot get to or maintain (if cued) 90 (or 45) degrees, drifts down to bed, but has

some effort against gravity. 3 = No effort against gravity, arm falls.

4 = No movement. 9 = Amputation, joint fusion -explain:

5.Right Arm

6. Left Arm

Leg

0 = No drift, leg holds 30 degrees position for full 5 seconds.

1 = Drift, leg falls by the end of the 5 second period but does not hit bed.

2 = Some effort against gravity, leg falls to bed by 5 seconds, but has some effort

against gravity. 3 = No effort against gravity, leg falls to

bed immediately.

4 = No movement. 9 = Amputation, joint fusion -explain:

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7.= Right Leg

8. = Left Leg

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9. Limb Ataxia: This item is aimed at finding evidence of a unilateral cerebellar lesion. Test with eyes

open. In case of visual defect, ensure testing is done in intact visual field. The finger-nose-finger and heel-shin tests are

performed on both sides, and ataxia is scored only if present out of proportion to weakness. Ataxia is absent in the patient who cannot understand or is hemiplegic.

Only in the case of amputation or joint fusion may the item be scored “9”, and the examiner must clearly write the explanation for not scoring. In case of blindness, test

by touching nose from extended arm position.

0 = Absent. 1 = Present in one limb. 2 = Present in two limbs.

10. Sensory: Sensation or grimace to pinprick when

tested, or withdrawal from noxious stimulus in the obtunded or aphasic patient. Only sensory loss attributed to stroke is scored as abnormal and the examiner should test

as many body areas [arms (not hands), legs, trunk, face] as needed to accurately check for hemisensory loss. A score of 2,

“severe or total”, should only be given when a severe or total loss of sensation can be

clearly demonstrated. Stuporous and aphasic patients will therefore probably

score 1 or 0. The patient with brainstem stroke who has bilateral loss of sensation is scored 2. If the patient does not respond and is quadriplegic, score 2. Patients in

coma (item 1a=3) are arbitrarily given a 2 on this item.

0 = Normal; no sensory loss. 1 = Mild to moderate sensory loss; patient

feels pinprick is less sharp or is dull on the affected side; or there is a loss of

superficial pain with pinprick but patient is aware he/she is being touched.

2 = Severe to total sensory loss; patient is not aware of being touched.

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11. Best Language: A great deal of information about

comprehension will be obtained during the preceding sections of the examination. The

patient is asked to describe what is happening in the attached picture, to name the items on the attached list of sentences.

Comprehension is judged from responses here as well as to all of the commands in

the preceding general neurological exam. If visual loss interferes with the tests, ask the

patient to identify objects placed in the hand, repeat, and produce speech. The

intubated patient should be asked to write. The patient in coma (question 1a = 3) will

arbitrarily score 3 on this item. The

0 = No aphasia, normal. 1 = Mild to moderate aphasia; some obvious loss of fluency or facility of comprehension, without significant

limitation on ideas expressed or form of expression. Reduction of speech and/or

comprehension, however, makes conversation about provided material

difficult or impossible. For example, in conversation about provided materials examiner can identify picture or naming

card from patient’s response. 2 = Severe aphasia; all communication is

through fragmentary expression; great need for inference, questioning, and guessing by the listener. Range of

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examiner must choose a score in the patient with stupor or limited cooperation

but a score of 3 should be used only if the patient is mute and follows no one step

commands.

information that can be exchanged is limited; listener carries burden of

communication. Examiner cannot identify materials provided from patient response.

3 = Mute, global aphasia; no usable speech or auditory comprehension.

12. Dysarthria: If the patient is thought to be normal, an

adequate sample of speech must be obtained by asking patient to read or repeat words from the attached list. If the patient

has severe aphasia, the clarity of articulation of spontaneous speech can be

rated. Only if the patient is intubated or has other physical barrier to producing speech

may the item be scored “9", and the examiner must clearly write an explanation for not scoring. Do not tell the patient why

he/she is being tested.

0 = Normal. 1 = Mild to moderate; patient slurs at least

some words and, at worst, can be understood with some difficulty.

2 = Severe; patient’s speech is so slurred as to be unintelligible in the absence of or out of proportion to any dysphasia, or is

mute/anarthric. 9 = Intubated or other physical barrier -

explain:

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13. Extinction and Inattention (formerly Neglect)

Sufficient information to identify neglect may be obtained during the prior testing. If

the patient has severe visual loss preventing visual double simultaneous

stimulation, and the cutaneous stimuli are normal, the score is normal. If the patient has aphasia but does appear to attend to

both sides, the score is normal. The presence of visual spatial neglect or anosagnosia may also be taken as

evidence of neglect. Since neglect is scored only if present, the item is never

untestable.

0 = No abnormality. 1 = Visual, tactile, auditory, spatial, or personal inattention or extinction to

bilateral simultaneous stimulation in one of the

sensory modalities. 2 = Profound hemi-inattention or hemi-inattention to more than one modality.

Does not recognize own hand or orients to only one side of space.

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Total Max

score 42

Total Max

score 42

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Nursing Protocol Nursing Care Following Thrombolysis for Stroke

1. Patient to be nursed in identified bed space that allows for continuous observation.

2. Oxygen, Suction, Cardiac Monitor, Sphygmomanometer, O2 Saturation machine should be

available at the bed side. Capillary blood glucose machine, Anaphylaxis box should be easily accessible.

3. Initiate post administration thrombolysis care plan on arrival

4. Perform patient observations as indicated and record a baseline ECG

5. If there are any concerns, medical review is essential. Report, review, document and

increase frequency of observations accordingly.

6. Pyrexia > 37°C should be treated with PR or PO Paracetamol (1g 4-6 hourly. No more than 4g in 24 hours)

7. If haemorrhage is suspected, report immediately and arrange for urgent medical

review. Send urgent FBC, clotting and group and save

8. If anaphylaxis is suspected (Tachypnoea, dyspnoea, tachycardia, swelling, rash) Stop infusion and employ anaphylaxis protocol. Arrange for urgent medical review or perform a crash call (2222) if required

9. Avoid catheterisation for 24 hours following thrombolysis infusion to minimise the risk of

trauma and bleeding. If essential, consult with medical team.

10. Do not insert naso gastric tubes for 24 hours post thrombolysis infusion to minimise the risk of trauma and bleeding

11. IM injections should be avoided for 48 hours post thrombolysis infusion to minimise the

risk of excessive bruising

12. Avoid giving heparin / warfarin. Refer to medical staff before commencing any anti coagulant or antiplatelet therapy (only given if CT at 24h shows no bleeding).

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Observations following administration of thrombolysis for stroke

Manual BP, Pulse, Temperature, Respirations,

GCS and Oxygen Saturations (NEWS Score – Refer to local

Guidelines)

Every 15 minutes for 2 hours

Every 30 minutes for 6 hours

Hourly for 18 hours

Maintain BP < Systolic 180 / Diastolic 105

Temperature not to exceed 37°C.

Observe for signs of raised intracranial pressure or intracranial bleeding

Unequal pupils Sudden drop in GCS Onset of drowsiness Onset of nausea, vomiting (photophobia) Rising BP and falling pulse

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National Institute for Health Stroke Scale (NIHSS)

REFER TO LAMINATED FULL GUIDANCE FOR SCORING

Score

Score

Score

Score

Date and Time

1a. LOC Score 0-3

1b. LOC – Response to Questions Score 0-2

1c. LOC – Response to Commands Score 0-2

2. Best gaze Score 0-2

3. Visual fields Score 0-3

4. Facial palsy Score 0-3

5. Right Arm motor Score 0-4 or X if untestable

6. Left Arm motor Score 0-4 or X if untestable

7. Right Leg motor Score 0-4 or X if untestable

8. Left leg motor Score 0-4 or X if untestable

9. Ataxia Score 0-2 or X if untestable

10. Sensory Score 0-2

11. Best language Score 0-3

12. Dysarthria Score 0-2 or X if untestable

13. Neglect/Inattention Score 0-2

Total Score (0-42)

Short NIHSS scoring sheet This is master copy – patient packs

include this sheet which should be filed in medical notes with completed

inclusion/exclusion checklist

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Evidence for mechanical thrombectomy in acute ischemic stroke updated

November 2016 [1,7].

RCP NICE stroke guidelines (Oct 2016)

Patients with acute ischaemic stroke should be considered for

combination intravenous thrombolysis and intra-arterial clot extraction (using stent retriever and/or aspiration techniques) if they have a

proximal intracranial large vessel occlusion causing a disabling neurological deficit (National Institutes of Health Stroke Scale [NIHSS]

score of 6 or more) and the procedure can begin (arterial puncture) within 5 hours of known onset.

Patients with acute ischaemic stroke and a contraindication to intravenous thrombolysis but not to thrombectomy should be considered

for intra-arterial clot extraction (using stent retriever and/or aspiration techniques) if they have a proximal intracranial large vessel occlusion

causing a disabling neurological deficit (National Institutes of Health Stroke Scale[NIHSS] score of 6 or more) and the procedure can begin

(arterial puncture) within 5 hours of known onset.

Patients with acute ischaemic stroke causing a disabling neurological deficit (a National Institutes of Health Stroke Scale [NIHSS] score of 6 or

more) may be considered for intraarterial clot extraction (using stent retriever and/or aspiration techniques, with priorintravenous

thrombolysis unless contraindicated) beyond an onset-to-arterial puncture time of 5 hours if:

‒ the large artery occlusion is in the posterior circulation, in which case treatment up to 24hours after onset may be appropriate;

‒ a favourable profile on salvageable brain tissue imaging has been proven, in which casetreatment up to 12 hours after onset may be

appropriate. Hyperacute stroke services providing endovascular therapy should

participate in national stroke audit to enable comparison of the clinical

and organisational quality of their services with national data, and use

the findings to plan and deliver service improvements.

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Summary of Meta-analysis of 5 trials summary:

BACKGROUND

In 2015, five randomised trials showed efficacy of endovascular thrombectomy over standard

medical care in patients with acute ischaemic stroke caused by occlusion of arteries of the

proximal anterior circulation. In this meta-analysis the trial investigators, aimed to pool

individual patient data from these trials to address remaining questions about whether the

therapy is efficacious across the diverse populations included.

METHODS

We formed the HERMES collaboration to pool patient-level data from five trials (MR CLEAN,

ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND IA) done between December, 2010, and

December, 2014. In these trials, patients with acute ischaemic stroke caused by occlusion of

the proximal anterior artery circulation were randomly assigned to receive either endovascular

thrombectomy within 12 h of symptom onset or standard care (control), with a primary

outcome of reduced disability on the modified Rankin Scale (mRS) at 90 days. By direct access

to the study databases, we extracted individual patient data that we used to assess the

primary outcome of reduced disability on mRS at 90 days in the pooled population and

examine heterogeneity of this treatment effect across prespecified subgroups. To account for

between-trial variance we used mixed-effects modelling with random effects for parameters of

interest. We then used mixed-effects ordinal logistic regression models to calculate common

odds ratios (cOR) for the primary outcome in the whole population (shift analysis) and in

subgroups after adjustment for age, sex, baseline stroke severity (National Institutes of Health

Stroke Scale score), site of occlusion (internal carotid artery vs M1 segment of middle cerebral

artery vs M2 segment of middle cerebral artery), intravenous alteplase (yes vs no), baseline

Alberta Stroke Program Early CT score, and time from stroke onset to randomisation.

FINDINGS

We analysed individual data for 1287 patients (634 assigned to endovascular thrombectomy,

653 assigned to control). Endovascular thrombectomy led to significantly reduced disability at

90 days compared with control (adjusted cOR 2.49, 95% CI 1.76-3.53; p<0.0001). The

number needed to treat with endovascular thrombectomy to reduce disability by at least one

level on mRS for one patient was 2.6. Subgroup analysis of the primary endpoint showed no

heterogeneity of treatment effect across prespecified subgroups for reduced disability

(pinteraction=0.43). Effect sizes favouring endovascular thrombectomy over control were

present in several strata of special interest, including in patients aged 80 years or older (cOR

3.68, 95% CI 1.95-6.92), those randomised more than 300 min after symptom onset (1.76,

1.05-2.97), and those not eligible for intravenous alteplase (2.43, 1.30-4.55). Mortality at 90

days and risk of parenchymal haematoma and symptomatic intracranial haemorrhage did not

differ between populations.

INTERPRETATION

Endovascular thrombectomy is of benefit to most patients with acute ischaemic stroke caused

by occlusion of the proximal anterior circulation, irrespective of patient characteristics or

geographical location. These findings will have global implications on structuring systems of

care to provide timely treatment to patients with acute ischaemic stroke due to large vessel

occlusion.

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Education

Training for stroke thrombolysis is available as an e-learning package from the

RCHT electronic learning management website ESR. The course title is 156

Thrombolysis in Acute Stroke Patients Online and Employee Support is available on ext 5148.

For NIHSS training please visit the website: https://secure.trainingcampus.net/uas/modules/trees/windex.aspx?rx=nihss-

english.trainingcampus.net and enter your NHS email for account registration. NIHSS training needs to be renewed every 3 years and it is the responsibility

of the individual clinician to ensure training is in date.

The stroke team provide face to face training sessions if required. Please

contact Dr K Adie, consultant stroke physician k.adie@nhs.net

References

1. NICE Guidance TA 122 - Alteplase for the treatment of acute ischaemic stroke Intercollegiate Stroke Working Party.

2. National Clinical Guidelines for Stroke. Royal College of Physicians. 6th edition. 2016.

3. Berkhemer OA et al. Mr CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015;372(1):11

4. Goyal M et al, ESCAPE Trial Investigators. Randomized assessment of rapid

endovascular treatment of ischemic stroke. N Engl J Med. 2015;372(11):1019.

5. Saver JL et al. SWIFT PRIME Investigators. Stent-retriever thrombectomy after

intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015;372(24):2285

6. Campbell BC et al. Endovascular therapy for ischemic stroke with

perfusion-imaging selection. EXTEND-IA Investigators. N Engl J Med.

2015;372(11):1009.

7. Jovin et al. Thrombectomy within 8 hours after symptom onset in ischemic stroke. REVASCAT Trial Investigators. N Engl J Med.

2015;372(24):2296.

8. Goyal et al. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised

trials. HERMES collaborators. Lancet. 2016;387(10029):1723.

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3. Monitoring compliance and effectiveness Element to be monitored

Outcome of thrombolysis for individual patients

Lead Dr Katja Adie/ Dr Frances Harrington

Tool Sentinel Stroke National Audit Programme (SSNAP) from the Royal College of Physicians

Frequency Each thrombolysed patients details and outcomes are entered on to SSNAP

Reporting arrangements

Dr Adie reports outcome locally to the eldercare governance and Emergency Department meeting monthly SSNAP data is collected as part of the Trust Clinical Audit & Outcomes Programme on an ongoing basis SSNAP data is reported and published nationally and monitored by the Clinical Commissioning Group

Acting on recommendations and Lead(s)

Dr Adie, Dr Harrington

Change in practice and lessons to be shared

Required changes to practice will be identified and actioned within six months. Dr Adie and Dr Harrington as lead members of the team will take each change forward where appropriate.

4. Equality and Diversity 4.1 This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement.

4.2 Equality Impact Assessment

The Initial Equality Impact Assessment Screening Form is at Appendix 2.

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Appendix 1. Governance Information

Document Title Stroke Thrombolysis Guideline (Emergency Department run service)

Date Issued/Approved: 11/11/2016

Date Valid From: 11/11/2016

Date Valid To: 12/07/2019

Directorate / Department responsible

(author/owner): Dr Katja Adie and Frances Harrington, Consultant Physician, Eldercare RCHT

Contact details: 01872 252447/ 07717714009

Brief summary of contents Guideline for the administration of thrombolysis for acute ischaemic stroke

Suggested Keywords: Stroke, Thrombolysis, Alteplase

Target Audience RCHT PCH CFT KCCG

Executive Director responsible for Policy:

Malcolm Stewart

Date revised: 12/07/2017

This document replaces (exact title of previous version):

Clinical guideline to deliver safe and effective thrombolysis for acute ischaemic stroke using robust evidence based clinical criteria

Approval route (names of committees)/consultation:

Acute Stroke Group, SERCO, SWAST

Divisional Manager confirming approval processes

Naomi Wakeley

Name and Post Title of additional signatories

Not Required

Name and Signature of Divisional/Directorate Governance Lead confirming approval by specialty and divisional management meetings

Name:

Publication Location (refer to Policy on Policies – Approvals and Ratification):

Internet & Intranet Intranet Only

Document Library Folder/Sub Folder Clinical / Neurology and Stroke

Links to key external standards NICE Guidance TA122 - Alteplase for the treatment of acute ischaemic stroke National Stroke Guidelines 2016

Related Documents: Advanced Stroke Management Pathway

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Acute Stroke Management Stroke and TIA Multidisciplinary Care Pathway Secondary Prevention after Stroke or TIA

Training Need Identified? Yes. Learning and Development department have been informed.

Version Control Table

Date Versi

on No

Summary of Changes Changes Made by

(Name and Job Title)

July 2008 V1.0 Initial Issue

Dr F Harrington

Dec 2010 V2.0 Amendment to 24/7 service Dr F Harrington

3/9/12 V3.0 Extended age and treatment window Dr F Harrington

21/1/14 V4.0 Change of service provision from Eldercare to Emergency Department team

Dr F Harrington

2/10/2015 V5.0 Availability of intra-arterial treatment Dr F Harrington Dr K Adie A James

11/11/2016 V6.0 Updated Evidence and change in pathway Dr K Adie Dr F Harrington

11/7/2017 V7.0`

Updated Evidence Dr K Adie Dr F Harrington

All or part of this document can be released under the Freedom of Information

Act 2000

This document is to be retained for 10 years from the date of expiry.

This document is only valid on the day of printing

Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust

Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager.

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Appendix 2. Initial Equality Impact Assessment Form

Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Existing Evidence

Age Removal of upper age limit for stroke thrombolysis based on recent randomised controlled trials

Sex (male, female, trans-

gender / gender reassignment)

Race / Ethnic communities /groups

Name of service, strategy, policy or project (hereafter referred to as policy) to be assessed: Stroke Thrombolysis Guideline Extended Age and Treatment Window

Directorate and service area: Is this a new or existing Procedure? existing

Name of individual completing assessment: Dr F Harrington

Telephone: 01872 253290

1. Policy Aim*

To safely administer thrombolytic agent to acute ischaemic stroke patients using updated, clearly defined criteria

2. Policy Objectives*

Safe administration of emergency drug therapy Clear advice and guidance for staff involved in the administration of emergency treatment and aftercare of patients who have undergone thrombolysis for stroke

3. Policy – intended Outcomes*

As above

4. How will you measure the outcome?

Patient response to treatment Audit – ongoing local and RCP National Sentinel Stroke Audit Inclusion in international SITS-MOST register (Safe implementation of thrombolysis in stroke)

5. Who is intended to benefit from the Policy?

Patients: through the promotion of safe, effective, evidence based practice

6a. Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? b. If yes, have these groups been consulted? c. Please list any groups who have been consulted about this procedure.

Yes

Yes

Acute Stroke Group, SERCO, SWAST

7. The Impact Please complete the following table.

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Disability - Learning disability, physical disability, sensory impairment and mental health problems

Religion / other beliefs

Marriage and civil partnership

Pregnancy and maternity

Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian

You will need to continue to a full Equality Impact Assessment if the following have been highlighted:

You have ticked “Yes” in any column above and

No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or

Major service redesign or development

8. Please indicate if a full equality analysis is recommended. Yes No

9. If you are not recommending a Full Impact assessment please explain why.

Signature of policy developer / lead manager / director Date of completion and submission

Names and signatures of members carrying out the Screening Assessment

1. 2.

Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust’s web site. Signed _______________ Date ________________