The Dreadful Clot

Dr Buvanes CheliahMD (UKM) MOG (UKM)

Obstetrician & GynaecologistHospital Umum Sarawak

The Dreadful Clot

Dr Buvanes CheliahMD (UKM) MOG (UKM)

Obstetrician & GynaecologistHospital Umum Sarawak

VTE (venous thromboembolism) includes1.Deep vein thrombosis (DVT)2.Pulmonary embolism (PE)

In Malaysia, PE is the common cause of direct maternal death and it is rising trend

It is preventable cause of maternal death

VTE (venous thromboembolism) includes1.Deep vein thrombosis (DVT)2.Pulmonary embolism (PE)

In Malaysia, PE is the common cause of direct maternal death and it is rising trend

It is preventable cause of maternal death

INTRODUCTIONINTRODUCTION

Pulmonary embolism is the main cause of maternal mortality in Malaysia

and Sarawak

Pulmonary embolism is the main cause of maternal mortality in Malaysia

and Sarawak

WHY IN PREGNANCY ?WHY IN PREGNANCY ?

1. HYPERCOAGULABLE STATE !!!1. HYPERCOAGULABLE STATE !!!

WHY IN PREGNANCY ?WHY IN PREGNANCY ?

2. THROMBOPHILIA

condition where the blood clots more easily than normal. Up to 50% of people who have an episode of thrombosis like

DVT or PE may have this condition. Check or ask for documented history of;

1. Protein C deficiency2. Protein S deficiency3. Antiphospholipid syndrome 4. Factor V Leiden 5. Dysfibrinogenaemia6. Antithrombin deficiency

.

2. THROMBOPHILIA

condition where the blood clots more easily than normal. Up to 50% of people who have an episode of thrombosis like

DVT or PE may have this condition. Check or ask for documented history of;

1. Protein C deficiency2. Protein S deficiency3. Antiphospholipid syndrome 4. Factor V Leiden 5. Dysfibrinogenaemia6. Antithrombin deficiency

.

WHY EMBOLISM IN RISEWHY EMBOLISM IN RISE

• Increasing risk factors1.Obesity2.Comorbidities3.Older age at pregnancy

• Increasing risk factors1.Obesity2.Comorbidities3.Older age at pregnancy

“Thromboembolism remains a significant

but preventable cause of maternal

death”

“Thromboembolism remains a significant

but preventable cause of maternal

death”

“ SARAWAK VTE RISK MANAGEMENT”

“ SARAWAK VTE RISK MANAGEMENT”

THE VTE RISK MANAGEMENT PROGRAMME WAS IMPLEMENTED IN ALL MOH HOSPITALS

IN SARAWAK IN JULY 2013….

RISK SCORING FOR ANTENATAL AND POSTNATAL WOMEN FOR VTE IS PROBABLY THE MOST EFFECTIVE WAY OF IDENTIFYING

THOSE AT RISK AND REQUIRING PROPHYLAXIS TREATMENT WITH

THROMBOPROPHYLAXIS

RISK SCORING FOR ANTENATAL AND POSTNATAL WOMEN FOR VTE IS PROBABLY THE MOST EFFECTIVE WAY OF IDENTIFYING

THOSE AT RISK AND REQUIRING PROPHYLAXIS TREATMENT WITH

THROMBOPROPHYLAXIS

RISK SCORINGRISK SCORING

THE STRATEGIES……THE STRATEGIES……

1. CREATING AWARENESS1. CREATING AWARENESS

Health clinics: Should identify very high risk patients during antenatal period and manage or refer them appropriately. Screen using VTE Risk Assessment forms Hospital: VTE risk assessment should be undertaken during every admission and prior to discharge from the hospital.High Risk E-Discharge Notification plays an important role in communicating between hospitals and health side. Patients who are high risk of VTE or are on treatment should be included in the E-discharge for both antenatal and postnatal cases!

Health clinics: Should identify very high risk patients during antenatal period and manage or refer them appropriately. Screen using VTE Risk Assessment forms Hospital: VTE risk assessment should be undertaken during every admission and prior to discharge from the hospital.High Risk E-Discharge Notification plays an important role in communicating between hospitals and health side. Patients who are high risk of VTE or are on treatment should be included in the E-discharge for both antenatal and postnatal cases!

Awareness towards risk factor & sign and symptoms

Awareness towards risk factor & sign and symptoms

2. PREVENTION

2. PREVENTION 3. EARLY DETECTION3. EARLY DETECTION

IDENTIFY HIGH RISK PATIENTSIDENTIFY HIGH RISK PATIENTS

Clinic health staff are expected to be able to identify patients who are VERY HIGH RISK for VTE and manage them or refer accordingly

Nurses performing home visits should be assessing postnatal patients for VTE using the Postnatal VTE Risk assessment form.

Clinic health staff are expected to be able to identify patients who are VERY HIGH RISK for VTE and manage them or refer accordingly

Nurses performing home visits should be assessing postnatal patients for VTE using the Postnatal VTE Risk assessment form.

SARAWAK ANTENATAL AND POSTNATAL RISK

This assessment should be performed :-During antenatal period-During each hospital admission-Post delivery

Using Standard form (Sarawak thromboprophylaxis risk assessment form)

This assessment should be performed :-During antenatal period-During each hospital admission-Post delivery

Using Standard form (Sarawak thromboprophylaxis risk assessment form)

When to assess?When to assess?

Antenatal patient who come to clinic follow up When antenatal or postnatal patients are being admitted to the

hospital for any indications (includes those admitted to other departments)

Reassessment required if other complications developed during the hospital stay or need to stay longer than 3 days

Those considered at risk upon discharge (e.g. surgery) in the antenatal period, may also need thromboprophylaxis

Post delivery before discharge to assess if she needs thromboprophylaxis

Antenatal patient who come to clinic follow up When antenatal or postnatal patients are being admitted to the

hospital for any indications (includes those admitted to other departments)

Reassessment required if other complications developed during the hospital stay or need to stay longer than 3 days

Those considered at risk upon discharge (e.g. surgery) in the antenatal period, may also need thromboprophylaxis

Post delivery before discharge to assess if she needs thromboprophylaxis

Sarawak Antenatal & Postnatal VTE Risk Assessment Program:

Sarawak Antenatal & Postnatal VTE Risk Assessment Program:

This assessment should be performed at:• Antenatal follow up•During each hospital admission•Post delivery before discharge

Patients who should be given thromboprophylaxis:•ANTENATALLY – score > 3(duration to be discussed with specialist)

•POSTNATALLY – score > 2(duration of at least 1 week)

** To be implemented in all hospitals by 1st July,2013

FORMS……..FORMS……..

WHO NEEDS PROPHYLAXISWHO NEEDS PROPHYLAXIS

Patients who should be given thromboprophylaxis:1.ANTENATALLY – score > 32.POSTNATALLY – score > 2*

Low risk with score < 21.Early mobilization/encourage to ambulate2.Avoidance of dehydration3.To seek treatment early if feeling unwell4.To seek treatment early if develops signs & symptoms of DVT/PE5.+/- Compression or TED stocking

Counselling to be given to all pregnant women * Risk of VTE postnatal is higher (thus a lower score needed to

start thromboprophylaxis)

Patients who should be given thromboprophylaxis:1.ANTENATALLY – score > 32.POSTNATALLY – score > 2*

Low risk with score < 21.Early mobilization/encourage to ambulate2.Avoidance of dehydration3.To seek treatment early if feeling unwell4.To seek treatment early if develops signs & symptoms of DVT/PE5.+/- Compression or TED stocking

Counselling to be given to all pregnant women * Risk of VTE postnatal is higher (thus a lower score needed to

start thromboprophylaxis)

VTE Risk Assessment Management flowchart (admission)VTE Risk Assessment Management flowchart (admission)

Assess risk for VTEAssess risk for VTE

Score < 3Score < 3 Score > 3Score > 3

General advice (ambulate/avoid dehydration/seek treatment if unwell, +/- Compression stocking)

Reassess risk if requires prolonged admission or develops new problems

General advice (ambulate/avoid dehydration/seek treatment if unwell, +/- Compression stocking)

Reassess risk if requires prolonged admission or develops new problems

Non specialist hospital

Specialist hospital

Counsel patient appropriately

Initiate thromboprophylaxis (duration discuss with O&G specialist/buddy specialist)

E-Discharge Notifications (specific instructions, incl. home visits)

Home visit by health staff (review compliance, use check list)

Yellow coded: FMS/ Specialist f/up, shared care with clinic with MO possible

Counsel patient appropriately

Initiate thromboprophylaxis (duration discuss with O&G specialist/buddy specialist)

E-Discharge Notifications (specific instructions, incl. home visits)

Home visit by health staff (review compliance, use check list)

Yellow coded: FMS/ Specialist f/up, shared care with clinic with MO possible

Initiate thromboprophylaxis

Documented follow up plans

E-Discharge Notifications (specific instructions, incl. home visits)

Home visit by staff (review compliance, use check list)

Yellow coded: Specialist & FMS antenatal f/up

VTE Risk assessment on discharge ( postnatal)

Provide general advice on DVT/PE prevention

Provide general advice on DVT/PE prevention

< 2 post-natal risk< 2 post-natal risk 2 or more risk 2 or more risk

Non specialist hospitalNon specialist hospital Specialist hospitalSpecialist hospital

Give patient information leaflet

Advice on ambulation, importance of adequate fluid intake

Seek immediate treatment if symptomatic

Refer to hospital if develops new problems/complications

Home visit (look for symptoms’ of DVT/PE – checklist)

Give patient information leaflet

Advice on ambulation, importance of adequate fluid intake

Seek immediate treatment if symptomatic

Refer to hospital if develops new problems/complications

Home visit (look for symptoms’ of DVT/PE – checklist)

Counselling & give patient information leaflet

Initiate thromboprophylaxis (at least 1 week, if longer Rx needed consult O&G specialist)

E-Discharge Notifications (home visits compulsory)

MO/ FMS review at 1week (re-assess risk, may need longer Rx if still high risk – consult specialist)

 

 

 

 

Counselling & give patient information leaflet

Initiate thromboprophylaxis (at least 1 week, if longer Rx needed consult O&G specialist)

E-Discharge Notifications (home visits compulsory)

MO/ FMS review at 1week (re-assess risk, may need longer Rx if still high risk – consult specialist)

 

 

 

 

. OPTIONS OF DRUG AVAILABLE. OPTIONS OF DRUG AVAILABLE

Which thromboprophylaxis?Which thromboprophylaxis?

LMWH is preferred: once daily injection and safe enough to be self administered

Enoxaparine (Clexane) & tinzaparin (Innohep) clinically proven to be efficacious and safe in pregnancy but it is porcine based (Muslim patients have to be informed)

Heparin is effective and safe in pregnancy but requires BD dosing and need to be administered by a medical personnel as the risk is higher compared to LMWH

LMWH is preferred: once daily injection and safe enough to be self administered

Enoxaparine (Clexane) & tinzaparin (Innohep) clinically proven to be efficacious and safe in pregnancy but it is porcine based (Muslim patients have to be informed)

Heparin is effective and safe in pregnancy but requires BD dosing and need to be administered by a medical personnel as the risk is higher compared to LMWH

Fondaparinux is similar to ‘LMWH’ and is not porcine based but efficacy and safety in pregnancy and lactating mothers are not proven (patient needs to be counseled & the doctor can be held liable)

Ultimately, the patient needs to choose (fondaparinux not available in non specialist hospitals)

Fondaparinux is similar to ‘LMWH’ and is not porcine based but efficacy and safety in pregnancy and lactating mothers are not proven (patient needs to be counseled & the doctor can be held liable)

Ultimately, the patient needs to choose (fondaparinux not available in non specialist hospitals)

DRUG ISSUESDRUG ISSUES

Issue 1: Self Injections

Clexane and Tizaparin can be easily and safely injected by patient. (After been properly taught) Prefilled syringe Fixed dose

Heparin otherwise should only be administered by medical personnel as an inpatient or outpatient Risk of overdose ( need to withdraw a correct dose

from the vial- technically difficult for patient to do so)

Clexane and Tizaparin can be easily and safely injected by patient. (After been properly taught) Prefilled syringe Fixed dose

Heparin otherwise should only be administered by medical personnel as an inpatient or outpatient Risk of overdose ( need to withdraw a correct dose

from the vial- technically difficult for patient to do so)

Issue 1: Self Injections : CLEXANE

Heparin should only be administered by medical personnel as an inpatient or outpatient

Muzakarah Jawatankuasa Fatwa Majlis Kebangsaan Bagi Hal Ehwal Ugama Islam Malaysia Kali Ke-87 yang bersidang pada 23 – 25 Jun 2009 telah membincangkan Hukum Penggunaan Ubat Clexane Dan Fraxiparine. Muzakarah telah memutuskan bahawa:

Islam menegah penggunaan ubat dari sumber yang haram bagi mengubati sesuatu penyakit, kecuali dalam keadaan di mana tiada ubat dari sumber yang halal ditemui dan bagi menghindari kemudharatan mengikut kadar yang diperlukan sahaja sehingga ubat dari sumber yang halal ditemui.

Muzakarah Jawatankuasa Fatwa Majlis Kebangsaan Bagi Hal Ehwal Ugama Islam Malaysia Kali Ke-87 yang bersidang pada 23 – 25 Jun 2009 telah membincangkan Hukum Penggunaan Ubat Clexane Dan Fraxiparine. Muzakarah telah memutuskan bahawa:

Islam menegah penggunaan ubat dari sumber yang haram bagi mengubati sesuatu penyakit, kecuali dalam keadaan di mana tiada ubat dari sumber yang halal ditemui dan bagi menghindari kemudharatan mengikut kadar yang diperlukan sahaja sehingga ubat dari sumber yang halal ditemui.

Oleh itu, berhubung dengan penggunaan ubat Clexane dan Fraxiparine yang dianggap darurat kepada para pesakit bagi mencegah formulasi pembekuan darah secara serta merta ketika pesakit berada pada tahap kronik, Muzakarah memutuskan bahawa penggunaan kedua-dua jenis ubat ini adalah ditegah kerana ia dihasilkan dari sumber yang diharamkan oleh Islam, memandangkan pada masa ini telah terdapat alternatif ubat iaitu Arixtra (Fondaparinux) yang dihasilkan daripada sumber halal dan mempunyai fungsi serta keberkesanan yang sama dengan Clexane dan Fraxiparine.

Oleh itu, berhubung dengan penggunaan ubat Clexane dan Fraxiparine yang dianggap darurat kepada para pesakit bagi mencegah formulasi pembekuan darah secara serta merta ketika pesakit berada pada tahap kronik, Muzakarah memutuskan bahawa penggunaan kedua-dua jenis ubat ini adalah ditegah kerana ia dihasilkan dari sumber yang diharamkan oleh Islam, memandangkan pada masa ini telah terdapat alternatif ubat iaitu Arixtra (Fondaparinux) yang dihasilkan daripada sumber halal dan mempunyai fungsi serta keberkesanan yang sama dengan Clexane dan Fraxiparine.

But……Fondaparinux in Pregnancy

Not enough data on efficacy and safety No antidote

………………??? Alternative to clexane/tinzaparine/fraxiparine in obstetrics patients.

Options1. Unfractionated heparin

Currently we do not allow patient to administer the injections themselves (because of safety issue)

Have to go to hospital/nearest clinic to get injected. BD dose…..night dose ( limited number of clinic are open

at night)2. Fondaparinux

National O&G services do not endorse use of fondaparinux in pregnancy and puerperium (the doctor can held liable if complication developed/Patient has VTE)

Options1. Unfractionated heparin

Currently we do not allow patient to administer the injections themselves (because of safety issue)

Have to go to hospital/nearest clinic to get injected. BD dose…..night dose ( limited number of clinic are open

at night)2. Fondaparinux

National O&G services do not endorse use of fondaparinux in pregnancy and puerperium (the doctor can held liable if complication developed/Patient has VTE)

How long to treat?How long to treat?

Depends on how high is the risk

Those with previous VTE, thrombophilia or a combination of antenatal non modifiable factors that adds up to a score of > 3, would require thromboprophylaxis throughout pregnancy & up to 42 days post delivery

Those who develops transient or temporary conditions that increases the risk temporarily (e.g. admission > 3 days, surgery, hyperemesis gravidarum) only needs short term treatment

Those that had LSCS or surgery during pregnancy requires 7 days of treatment or longer if indicated

Depends on how high is the risk

Those with previous VTE, thrombophilia or a combination of antenatal non modifiable factors that adds up to a score of > 3, would require thromboprophylaxis throughout pregnancy & up to 42 days post delivery

Those who develops transient or temporary conditions that increases the risk temporarily (e.g. admission > 3 days, surgery, hyperemesis gravidarum) only needs short term treatment

Those that had LSCS or surgery during pregnancy requires 7 days of treatment or longer if indicated

When in doubt, consult an O&G specialist

Which patients will go to health clinic for injection ???Which patients will go to health clinic for injection ???

1. Patient on LMWH (Clexane/Tinzaparine) who are not keen for self injection.

2. Patient on Unfractionated heparin ( refused porcine based LMWH)

1. Patient on LMWH (Clexane/Tinzaparine) who are not keen for self injection.

2. Patient on Unfractionated heparin ( refused porcine based LMWH)

Not many patient Most Muslim patient are keen for

clexane/tinzaparine after counselling. Proportion of patient on unfractionated heparin

will receive the injection in the hospital.

Common Error !!!!!!! Of AdministrationCommon Error !!!!!!! Of Administration

The correct dose of unfractionated heparin is ……..

5000 unit B.DSubcutaneously

The correct dose of unfractionated heparin is ……..

5000 unit B.DSubcutaneously

Error encountered…….Error encountered…….

Heparin are given intra-mascularly instead of subcutaneously.

Overdose !!!!!...........few patient are wrongly given up to 25,000 unit b.d

Heparin are given intra-mascularly instead of subcutaneously.

Overdose !!!!!...........few patient are wrongly given up to 25,000 unit b.d

Subcutaneous injection : TechniqueSubcutaneous injection : Technique

Did not read the heparin concentration properly

1 vial = 5 ml 5000 unit = 1 ml Only 1 ml is needed

EARLY DETECTION !!!EARLY DETECTION !!!

1. E-Discharge informing health side on high risk patient.

2. Home visit within 7 days of discharge 3. VTE checklist during home visit by nurses.4. Patient information leaflet on VTE5. Patient information leaflet on heparin

Signs and Symptoms of DVTSigns and Symptoms of DVT

Important to note that half of all DVT cases are asymptomatic

DVT signs & symptoms includes; Swelling in one or both legs Pain or tenderness in one or both legs, which may occur only

while standing or walking Warmth in the skin of the affected leg Red or discoloured skin in the affected leg Leg fatigue

Especially when the above signs & symptoms occur suddenly

Sign & Symptoms of PE

Pulmonary embolism symptoms can vary greatly, depending on how much of your lung is involved, the size of the clot and your overall health

Signs and symptoms includes; Shortness of breath. This symptom typically appears

suddenly and occurs whether you're active or at rest. Chest pain. The pain will get worse with exertion but won't

go away when you rest. Cough. The cough may produce bloody or blood-streaked

sputum. Wheezing Clammy or bluish-coloured skin Excessive sweating Rapid or irregular heartbeat Weak pulse

THROMBOEMBOLISM CHECK LIST FOR ANTENATAL OR POST-NATAL HOME VISITS:

1) General well-being Y N

a) Is the patient ambulating? b) Is the patient drinking well? c) Does the patient look dehydrated? d) Does the patient have fever?

2) Signs & symptoms’ of DVT Y N a) Leg swelling (usually unilateral) b) Calf pain (even at rest) c) Redness of calf d) Feeling unwell (unable to mobilize) e) Non pitting swelling f) Increased warmth of the limb g) Reduced capillary filling

3) Signs & symptoms’ of pulmonary embolism Y N a) Shortness of breath b) Chest pain (more during breathing) c) Cough (dry or blood stained) d) Pulse rate >100 e) Respiratory rate >24 f) Cyanosis g) Unconscious

Please note:

• If a patient develops any of these signs or symptoms, refer immediately to the nearest clinic or hospital for review by a doctor.

• Please advise patients to ambulate, drink adequately and to seek medical treatment if feeling unwell during every visit

• Please ensure if the patient is compliant to the medication or injections being prescribed

Assessed by:

Name: ………………………………………………….. Signature: …………………………………………….. Date: ………………………

Health Nurses should use this form to assess patients during home visits: after Antenatal or

Postnatal Discharge

Health Nurses should use this form to assess patients during home visits: after Antenatal or

Postnatal Discharge

• If a patient develops any of these signs or symptoms, refer immediately to the nearest clinic or hospital for review by a doctor.

• Please advise patients to ambulate, drink adequately and to seek medical treatment if feeling unwell during every visit

• Check if the patient is compliant to treatment (Clexane/Tinzaparine/Heparin)

Thank You