Condition category
Circulatory System
Date applied
23/11/2010
Date assigned
28/01/2011
Last edited
24/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nikola Sprigg

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.1

Study information

Scientific title

A randomised controlled trial of Tranexamic acid in Intracerebral Haemorrhage (TICH)

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

Cambridgeshire 2 Research Ethics Committee, 01/11/2010, ref: 10/H0308/80

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase II

Drug names

Tranexamic acid (Cyklokapron®)

Primary outcome measures

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 trial start date

06/12/2010

Overall trial end date

06/06/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

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

Trial participating centre

University of Nottingham
Nottingham
NG5 1 PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

c/o Mr Paul Cartledge
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk

Funders

Funder type

University/education

Funder name

University of Nottingham (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Stroke Association

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24680087

Publication citations

Additional files

Editorial Notes