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STICH II Surgical Trial in Intracerebral Haemorrhage Recruitment and data collection progress to date Dr. Alina Andras Database Manager.

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Presentation on theme: "STICH II Surgical Trial in Intracerebral Haemorrhage Recruitment and data collection progress to date Dr. Alina Andras Database Manager."— Presentation transcript:

1 STICH II Surgical Trial in Intracerebral Haemorrhage Recruitment and data collection progress to date Dr. Alina Andras Database Manager

2 STICH II Funded by Medical Research Council (UK) and now managed by NIHR on behalf of the MRC-NIHR partnership (Efficiency and Mechanism Evaluation (EME) Programme) * Sponsored by Newcastle upon Tyne Hospitals NHS Foundation Trust Registered with Current Controlled Trials ISRCTN * The view and opinions expressed herein are those of the authors and do not necessarily reflect those of the Department of Health

3 STICH II - Objectives To establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar ICH will improve outcome compared to a policy of initial conservative treatment. To better define the indications for early surgery.

4 STICH II Main Features Multicentre randomised parallel group prospective trial Spontaneous lobar intracerebral haemorrhage Treating neurosurgeon must be in equipoise over treatment 600 patients Outcome at six months

5 Centre Recruitment: 111 centres – 31 March 2011

6 Centre Recruitment Registered Centres 111 Further with Ethics 28 Expressed Interest 99 UK (18) Aberdeen Brighton Cambridge Dundee Edinburgh Hull Leeds Liverpool London -St George’s National Hospital Newcastle upon Tyne N. Staffordshire Middlesbrough Oxford Preston Salford Southampton Swansea Europe (55) Amberg, Germany Athens, Greece Berlin, Germany (x2) Bialystok, Poland Bilbao, Spain Borsod County, Hungary Brno, Czech Republic (x2) Chisinau, Moldova Cluj, Romania Dessau, Germany Dusseldorf, Germany Erlangen, Germany Granada, Spain Griefswald, Germany Groningen, Netherlands Heidelberg, Germany Istanbul, Turkey Jena, Germany Kassel, Germany Klaipeda, Lithuania Lübeck, Germany Liberec, Czech Republic Magdeburg, Germany Münster, Germany (x2) Novosibirsk, Russia Olomouc, Czech Republic Ostrava, Czech Republic Pecs, Hungary Poznan, Poland Prague, Czech Republic Riga, Latvia (x2) Rome, Italy Saarbruecken, Germany Saarland, Germany Santander, Spain Siegen, Germany Skopje, Macedonia Tbilisi, Georgia Thessaloniki, Greece (x2) Timisoara, Romania Trondheim, Norway Uppsala, Sweden Valladolid, Spain Vienna, Austria Wiesbaden, Germany Yerevan State, Armenia Outside Europe (38) Albany, NY, USA Bangalore, India Beijing, China Bloomington, USA Calcutta, India Colombo, Sri Lanka Dhaklria, India Dharan, Nepal Edmonton, Canada Guadalajara, Mexico Gwarko, Nepal Haifa, Israel Hartford USA Haryana, India Hyderabad, India (x2) Kansas, USA Kubang Kieran, Malaysia Lahore, Pakistan Loyola, USA Ludhiana, India Macon, USA Maharashtra, India Mansoura, Egypt Mayo, Jacksonville, USA Melbourne, Australia New Delhi, India Penn State, USA Peshawar, Pakistan Riyadh, KSA Seoul, South Korea Shanghai, China Temple, USA Tianjin, China Tlalpan, Mexico Tokyo, Japan Trivandrum, India (x2) Vishakhapatnam, India Zagazig, Egypt

7 STICH II patients’ recruitment –Eligibility –Randomisation –Data collection Randomisation Two week CTs Adverse Events Outcome

8 STICH II- Inclusion criteria Evidence of spontaneous lobar ICH on CT scan (1cm or less from cortex surface) Patient within 48 hours of ictus Best MOTOR score on GCS of 5 or 6 and best EYE score on GCS of 2 or more Volume of haematoma between 10 and 100ml (using Broderick method) Clinical equipoise

9 STICH II- exclusion criteria Clear evidence that the ICH is due to an aneurysm or angiographically proven AVM Intraventricular haemorrhage of any sort Hydrocephalus ICH secondary to tumour or trauma Basal ganglia, thalamic, cerebellar or brainstem ICH or extension of lobar ICH into any of these regions Severe pre-existing physical or mental disability or severe co-morbidity that might interfere with assessment of outcome If surgery cannot be performed within 12 hours

10 Example CT scans of patients with intracerebral haematomas that would and would not be eligible for STICH II Example 1 This picture shows a scan of a patient who would be eligible for STICH II. The patient has a lobar intracerebral haematoma, close to the cortical surface. The volume of the haematoma is within the 10 – 100 ml criterion. There is no evidence of hydrocephalus or intraventricular haemorrhage and the haematoma does not extend into the basal ganglia, and is not associated with trauma, tumour or aneurysm. Example 2 In contrast this picture shows the scan of a patient who has a haematoma that would exclude them from STICH II. The haematoma is not within 1cm of the cortical surface of the brain. It extends from the lobar region into the basal ganglia. There is evidence also of intraventricular haemorrhage. IncludedExcluded

11 STICH II - Recruitment Patient satisfies criteria –has had a CT scan to confirm the diagnosis, size and location of the haematoma. Consent or assent obtained –Information sheet is given to patient/relative with time to ask questions –Written witnessed informed consent from the patient or the person with the closest personal relationship with the patient who is themselves capable and willing to assent on behalf of the patient. –Copies given to patient and filed in notes and site project file Complete pre-randomisation record Web and phone 24 hour randomisation service based in Aberdeen HSRU Allocation –stratified by country and method of surgery –with a minimisation algorithm based on age group and neurological deficit with a random component

12 Patient Recruitment: 432 patients, 111 centres – 31 March 2011

13 Recruitment by Centre 66 out of 111 (60%) centres have recruited at least one patient

14 Recruitment by Country Patients have been recruited from 25 countries.

15 Patient Demographics Gender (%) Age Figures produced for 432 cases Median Age = 65 years Min = 17 years, Max = 94 years

16 Haematoma Characteristics Side (%) Volume (ml)Depth (mm from Cortex) Figures produced for 432 cases Median volume =37 ml Min = 10ml Max = 100ml Median depth = 1mm 48% 52%

17 Total GCS at randomisation Figures produced on 31/03/2011 for 432 cases. Median GCS = 13

18 Neurological Deficits: % Normal% Weak% Paralysed ARM LEG OVERALL274033

19 Hours to Randomisation Median = 22 hours

20 Past medical history: 66% history of hypertension 47% on anti-hypertensives 5% previous MI 10% previous stroke

21 Medical treatment At time of ICH – 7% anti coagulants –11% anti platelet therapy – 1% recent thrombolytic therapy Following ICH – 1% Factor VII –11% other coagulants 26% had an angiogram –93% no sig vascular lesion, 5% AVM, 3% Aneurysm

22 Previous functional status: Pre-ICH Rankin Score: Rankin Score% with score 0 - well78% 1 – Minor symptoms15% 2 – Minor handicap5% 3 – Moderate handicap1% 4 – Needs lots of help with ADL1% 5 – Needs constant care0% Mobility Score% with score 1- able to walk 200m outside93% 2 – able to walk indoors6% 3 – unable to walk without help1% Pre-ICH Mobility:

23 Status at 2 weeks: 35% Discharged from hospital 32% Still on neurosurgical ward 26% Transferred 7% Dead

24 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

25

26 Randomisation forms CT scans Discharge/ 2 week follow-up form (Cross-over forms) Adverse Event Form 6 month follow up: – Cover letter – Form Screening logs Commitments from collaborators

27 MRC Good clinical trials guidelines Trial Management Team Trial Steering Committee Data Monitoring Committee (DMC) Ethical Approval and R & D Approval (UK) Sub agreement

28 Acknowledgements Steering and Data Monitoring Committees All Co-investigators All patients and carers Medical Research Council


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