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| [ ...Back to search results ] | [ Print-friendly version ] |
| Tranexamic acid in IntraCerebral Haemorrhage |
| ISRCTN | ISRCTN50867461 |
| ClinicalTrials.gov identifier | |
| Public title | Tranexamic acid in IntraCerebral Haemorrhage |
| Scientific title | A randomised controlled trial of Tranexamic acid in Intracerebral Haemorrhage (TICH) |
| Acronym | TICH |
| Serial number at source | Version 1.1 |
| Study hypothesis |
Primary:
To test the feasibility, tolerability and acceptability (adverse events) of tranexamic acid in haemorrhagic stroke. Secondary: To test the effects of tranexamic acid on haematoma expansion and death and dependency in haemorrhagic stroke. |
| Lay summary | |
| Ethics approval | Cambridgeshire 2 Research Ethics Committee approved on the 1st November 2010 (ref: 10/H0308/80) |
| Study design | Randomised double blind placebo controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Stroke - primary intracerebral haemorrhage |
| Participants - inclusion criteria |
1. Adult patients (aged over 18 years, either sex) with primary intracerebral haemorrhage confirmed on computed tomography (CT) brain scan
2. Event less than 24 hours of onset (sleep stroke - onset as bed time) |
| Participants - exclusion criteria |
1. Secondary haemorrhagic stroke (anticoagulation, known vascular malformations)
2. Previous venous thrombo-embolic disease 3. Recent (within 12 months) ischaemic events (ischaemic stroke, myocardial infarction, peripheral artery disease) 4. Renal impairment (estimated glomerular filtration rate [eGRF] less than 50 mmol) 5. Pregnancy or breast feeding (pregnancy will be excluded in female patients of child bearing age with a urine pregnancy test) |
| Anticipated start date | 06/12/2010 |
| Anticipated end date | 06/06/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 24 |
| Interventions | Intravenous tranexamic acid (Cyklokapron®) or 0.9% normal saline administered as 1 g loading dose infusion over 10 minutes followed by 1 g infusion over 8 hours. |
| Primary outcome measure(s) |
1. Acceptability: number of patients screened that are eligible for enrolment that give informed consent
2. Tolerability: adverse events after tranexamic acid administration |
| Secondary outcome measure(s) |
Surrogate markers of efficacy:
1. Radiological: haematoma volume change on brain imaging Day 1 to Day 2 2. Haematological: full blood count (FBC) and clotting function at Day 2 3. Day 7 (or discharge from hospital) and Day 90 (end of follow-up): 3.1. Dependency (modified Rankin Scale shift) 3.2. Disability (change in BI) 3.3. Quality of life (EuroQoL) 3.4. Care giver burden (GHQ-28) 3.5. Mood (Zung depression score) 3.6. Cognition (MMSE) |
| Sources of funding |
1. University of Nottingham (UK)
2. The Stroke Association (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Nikola Sprigg |
| Address |
Clinical Sciences Building
University of Nottingham Hucknall Road |
| City/town | Nottingham |
| Zip/Postcode | NG5 1 PB |
| Country | United Kingdom |
| Sponsor | University of Nottingham (UK) |
| Address |
c/o Mr Paul Cartledge
Research Innovation Services Kings Meadow Campus Lenton Lane |
| City/town | Nottingham |
| Zip/Postcode | NG7 2NR |
| Country | United Kingdom |
| Sponsor website: | http://www.nottingham.ac.uk |
| Date applied | 23/11/2010 |
| Last edited | 28/01/2011 |
| Date ISRCTN assigned | 28/01/2011 |
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