Tranexamic acid in IntraCerebral Haemorrhage
| ISRCTN | ISRCTN50867461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50867461 |
| Secondary identifying numbers | Version 1.1 |
- Submission date
- 23/11/2010
- Registration date
- 28/01/2011
- Last edited
- 24/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Nikola Sprigg
Scientific
Scientific
Clinical Sciences Building
University of Nottingham
Hucknall Road
Nottingham
NG5 1 PB
United Kingdom
Study information
| Study design | Randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of Tranexamic acid in Intracerebral Haemorrhage (TICH) |
| Study acronym | TICH |
| 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. |
| Ethics approval(s) | Cambridgeshire 2 Research Ethics Committee, 01/11/2010, ref: 10/H0308/80 |
| Condition | Stroke - primary intracerebral haemorrhage |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Tranexamic acid (Cyklokapron®) |
| Primary outcome measure | 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 measures | 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) |
| Overall study start date | 06/12/2010 |
| Overall study end date | 06/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Participant 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) |
| Participant 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) |
| Recruitment start date | 06/12/2010 |
| Recruitment end date | 06/06/2012 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
University of Nottingham
Nottingham
NG5 1 PB
United Kingdom
NG5 1 PB
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
c/o Mr Paul Cartledge
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
University/education
University of Nottingham (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Stroke Association
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2014 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
