Tranexamic acid in IntraCerebral Haemorrhage

ISRCTN	ISRCTN50867461
DOI	https://doi.org/10.1186/ISRCTN50867461
Protocol serial number	Version 1.1
Sponsor	University of Nottingham (UK)
Funders	University of Nottingham (UK), Stroke Association

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 of protocol

Not provided at time of registration

Contact information

Dr Nikola Sprigg
Scientific

Clinical Sciences Building
University of Nottingham
Hucknall Road
Nottingham
NG5 1 PB
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial of Tranexamic acid in Intracerebral Haemorrhage (TICH)
Study acronym	TICH
Study objectives	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
Health condition(s) or problem(s) studied	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
Phase	Phase II
Drug / device / biological / vaccine name(s)	Tranexamic acid (Cyklokapron®)
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
Key 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)
Completion date	06/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	24
Key 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)
Key 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)
Date of first enrolment	06/12/2010
Date of final enrolment	06/06/2012

Locations

Countries of recruitment

United Kingdom

Study participating centre

University of Nottingham

Nottingham
NG5 1 PB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes