Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage TICH-2 - Tranexamic acid for IntraCerebral Haemorrhage TICH-2

Phase 1

• Conditions: Primary Intracerebral Haemorrhage; MedDRA version: 18.0Level: LLTClassification code 10022753Term: Intracerebral haemorrhageSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-004108-37-HU
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-27
• Study Completion: 2018-02-28
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2325

Inclusion Criteria

Adult (=18 years) patients with acute PICH within 8 hours of stroke onset. (Where stroke onset time is unknown, the time of when last known well will be used.)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 667
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1333

Exclusion Criteria

1)Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis or known underlying structural abnormality such as arterial venous malformation, aneurysm, tumour, venous thrombosis as cause for the intracerebral haemorrhage.. Note it is not necessary to exclude an underlying abnormality prior to enrolment, but where a secondary cause of haemorrhage is known, these patients should not be recruited.
2)Patients for whom tranexamic acid is thought to be contraindicated.
3)Patients with pre-morbid dependency (mRS>4).
4)Participation in another drug trial concurrently.
5)Pre-stroke life expectancy <3 months (eg. advanced metastatic cancer).
6)Coma – Glasgow coma scale <5

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified