Study start date 1 September 2009

Site and patient recruitment opened 1 October 2009

Patient recruitment due to close 29 March 2013

Last Six month due 30 September 2013

Study finishes 28 February 2014

Pilot Target 1 Not less than 12 centres signed up at the end of

year 1.

Target met – 22 centres were actually signed up in the first 12 months!

Pilot Target 2Average recruitment rate must be at least 2

patients per centre year during the first 12 recruiting centre years.

Target met

Pilot TargetActual patient

840 patients in total

100 UK patients

Interim target: 120 patients by 31/10/2011 (including 12 UK patients)

Aim to register 150-200 sites.

Sites are encouraged to begin active patient screening as soon as they receive their site files.

Each site to aim to recruit 3 patients per year (and achieve a minimum of 1 patient per year).

UK (4)• Dundee • Newcastle upon Tyne• Haywards Heath• Southampton

Europe (12)• Brno, Czech Republic• Heidelberg, Germany• Jena, Germany• Kaunas, Lithuania• Klaipeda, Lithuania• Munchen, Germany• Rome, Italy• Santander, Spain• Szeged, Hungary• Timisoara, Romania• Ulm, Germany• Yerevan, Armenia

Outside Europe (21)• Albany, USA • Bangalore, India• Beijing Tiantan, China• Biratnagar, Nepal• Calcutta, India• Chennai, India• Dehradun, India• Haryana, India• Hyderabad, India• Kerala, India• Kubang Kerian, Malaysia• Lucknow, India• Ludhiana, India• Maharashtra, India• Mysore, India• Pennsylvania, USA• Peshawar, Pakistan• Shanghai, China• Tianjin, China• Vishakhapatnam, India• Zagazig, Egypt

Expressed Interest 94

Further with Ethics 10

Registered Centres 37

Completed site questionnaire

Ethics and/or R&D/local regulations

Ethics + Tripartite site agreement signed

Centre Recruitment36 centres on 31/03/2011

Patient Recruitment n=52 on 31/03/2011

Median age =53 years (min =16, max =83)

Median Total GCS =12Min = 5Max=15

Median Primary Haematoma Volume = 21ml(Min =11ml, Max=96 ml)

25% of cases have a second haematoma (median vol=3ml)

Early Surgery conservative

Conservative Early Surgery

They can potentially “pollute” the interpretation of the trial results.

Of those randomised to early surgery:24% did not have surgery.

Of those having early surgery:

42% had surgery in under 3 hours 26% had surgery between 3-6 hours 10% had surgery between 6-12 hours 22% exact timing data still to be returned

Of those randomised to initial conservative treatment 22% had surgery

Of those having surgery:50% had the surgery in under 12 hours

Mechanism of Injury(for the first 46 patients)

0

1

2

3

4

5

6

7

8

9

10

Number of patients randomised by centre (at end March 2011)

Acknowledgements

• Funding agencies• Steering and Data Monitoring

Committees• All Co-investigators• All patients and carers• STITCH Trauma Office team!

Research.ncl.ac.uk/trauma.stitch email:trauma.stitch@ncl.ac.ukDepartment of Health Disclaimer:

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Department of Health.

Do any centres have specific problems?