Treatment, outcome and plans
for the final phase
Dr Barbara A Gregson
Trial Director
Treatments
Study Flow Chart
Diagnostic CT
Equipoise
Consent to STICH II
Telephone randomisation service (24 hours) or web service
Initial Conservative
Treatment
Early Surgery
• 5 Days GCS Monitoring
• Day 5 CT
• Discharge / 2 week form
6 month outcome questionnaire
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
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
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)
Outcomes
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
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• 3 patients have withdrawn following randomisation.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
– 78% living with family
– 13% in residential/nursing homes
23% with Severe Disability
51% with SD
60% with SD in residential
88% with SD in nursing homes.
Modified Rankin Scale at six months
Glasgow Outcome Scale at six months
Outcome and age
Outcome and volume of
haematoma
Outcome and GCS
Plans for the final phase
Recruitment rate over time
Six month period
patients recruited
during period
centre-months of
recruitment
patients per centre
per month
Dec 06 – May 07
8
20
0.4
June 07 – Nov 07
18
111
0.162
Dec 07 – May 08
32
204
0.157
June 08 – Nov 08
45
314
0.143
Dec 08 – May 09
66
417
0.158
June 09 – Nov 09
71
462
0.154
Dec 09 – May 10
68
515
0.132
June 10 – Nov 10
71
560
0.127
Recruitment pattern by month
- up to 31 March 2011
Recruitment pattern by quarter
- up to 31 March 2011
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
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
Publications
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.
To join the study contact:
•
• Website: www.research.ncl.ac.uk/stich
•
Email:
[email protected]
•
•
Tel:
Fax:
+44 191 222 5761
+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.