2.  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

3. 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 2 Average recruitment rate must be at least 2 patients per centre year during the first 12 recruiting centre years. Target met

4. Pilot Target Actual patient

5.  840 patients in total  100 UK patients Interim target:  120 patients by 31/10/2011 (including 12 UK patients)

6.  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).

8. 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

9. Centre Recruitment 36 centres on 31/03/2011

10. Patient Recruitment n=52 on 31/03/2011

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

13. Median Total GCS =12 Min = 5 Max=15

14. Median Primary Haematoma Volume = 21ml (Min =11ml, Max=96 ml) 25% of cases have a second haematoma (median vol=3ml)

16.  Early Surgery conservative  Conservative Early Surgery  They can potentially “pollute” the interpretation of the trial results.

17.  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

18.  Of those randomised to initial conservative treatment 22% had surgery Of those having surgery: 50% had the surgery in under 12 hours

19. Mechanism of Injury (for the first 46 patients)

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

23.  Do any centres have specific problems?