1. Treatment, outcome and plans for the final phase Dr Barbara A Gregson Trial Director

2. Treatments

3. Study Flow Chart 5 Days GCS Monitoring Day 5 CT Discharge / 2 week form 6 month outcome questionnaire Diagnostic CT Equipoise Consent to STICH II Telephone randomisation service (24 hours) or web service Initial Conservative Treatment Early Surgery

4. STICH II - treatments Early surgery –Craniotomy performed as soon as possible (within 12 hours) –Best medical treatment Initial conservative treatment –Best medical treatment –Delayed evacuation if patient deteriorates and it becomes clinically appropriate

5. Compliance with treatment allocation: surgery group Of those randomised to surgery: -43% had surgery in under 3 hours -27% had surgery between 3-6 hours -21% had surgery between 6-12 hours - 4% had surgery in over 12 hours - 6% did not have surgery

6. Compliance with treatment allocation: conservative group Of those randomised to initial conservative treatment: – 20% had surgery. Of those having surgery: – 32% had surgery in under 12 hours (6% of total)

7. Outcomes

8. Outcome measurement Confirm patient’s status (any major adverse events) and address Six month structured postal questionnaire sent by STICH Office to patient for completion by patient or carer –Primary Extended GOS –Secondary Rankin EuroQol Residence Focal deficits Other problems Analysis by intention to treat

9. Outcome for first 350 patients 6 month primary outcome data obtained for 329 (94%) patients (20/04/2011) 75 died (23%), 254 completed postal questionnaires were returned. 3 patients have withdrawn following randomisation. Residence at 6 months – 9% living at home alone 23% with Severe Disability –78% living with family 51% with SD –13% in residential/nursing homes 60% with SD in residential 88% with SD in nursing homes. EuroQol (EQ-5D) records how patients perceive their problems within each dimension: Level 1: No problems Level 2: Some/moderate problems Level 3: Extreme problems

10. Modified Rankin Scale at six months EuroQol (EQ-5D) records how patients perceive their problems within each dimension: Level 1: No problems Level 2: Some/moderate problems Level 3: Extreme problems

11. Glasgow Outcome Scale at six months EuroQol (EQ-5D) records how patients perceive their problems within each dimension: Level 1: No problems Level 2: Some/moderate problems Level 3: Extreme problems

12. Outcome and age

13. Outcome and volume of haematoma

14. Outcome and GCS

15. Plans for the final phase

16. Recruitment rate over time Six month period patients recruited during period centre-months of recruitment patients per centre per month Dec 06 – May 078200.4 June 07 – Nov 07181110.162 Dec 07 – May 08322040.157 June 08 – Nov 08453140.143 Dec 08 – May 09664170.158 June 09 – Nov 09714620.154 Dec 09 – May 10685150.132 June 10 – Nov 10715600.127

17. Recruitment pattern by month - up to 31 March 2011

18. Recruitment pattern by quarter - up to 31 March 2011

19. Review of progress towards final recruitment target Target total Planned recruitment (Extension 29/08/08) Actual recruitment Planned recruitment (Dec 2009 to bring on target) Assuming 15 per month Assuming 12 per month Area enlarged in following slide

20. Review of progress towards final recruitment target Target total Planned recruitment (Extension 29/08/08) Actual recruitment Planned recruitment (Dec 2009 to bring on target) Assuming 15 per month Assuming 12 per month

21. Publications

22. Conclusions Crossover rates are lower than in STICH but could be lower still. Ongoing six month follow up rate is 94%. 34% of patients make either a good recovery or have moderate disability according to the Glasgow Outcome Scale. To attain our target of 600 patients centres need to continue to develop their patient screening strategies and increase their recruitment rates. All sites who recruit patients will be acknowledged in the publication of the final results.

23. To join the study contact: Website: www.research.ncl.ac.uk/stichwww.research.ncl.ac.uk/stich Email: stich@ncl.ac.ukstich@ncl.ac.uk Tel: +44 191 222 5761 Fax: +44 191 222 5762 Address: Neurosurgical Trials Unit Newcastle University 3-4 Claremont Terrace Newcastle upon Tyne NE2 4AE Department of Health Disclaimer: The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Department of Health.