Tranexamic acid in IntraCerebral Haemorrhage

Completed

Conditions: Stroke - primary intracerebral haemorrhage
Circulatory System
Stroke

Registration Number: ISRCTN50867461

Lead Sponsor: niversity of Nottingham (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 24

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)

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Acceptability: number of patients screened that are eligible for enrolment that give informed consent<br>2. Tolerability: adverse events after tranexamic acid administration

Secondary Outcome Measures

Name	Time	Method
Surrogate markers of efficacy:<br>1. Radiological: haematoma volume change on brain imaging Day 1 to Day 2<br>2. Haematological: full blood count (FBC) and clotting function at Day 2<br>3. Day 7 (or discharge from hospital) and Day 90 (end of follow-up):<br>3.1. Dependency (modified Rankin Scale shift)<br>3.2. Disability (change in BI)<br>3.3. Quality of life (EuroQoL)<br>3.4. Care giver burden (GHQ-28)<br>3.5. Mood (Zung depression score)<br>3.6. Cognition (MMSE)