Tranexamic acid for IntraCerebral Haemorrhage (TICH-2)

Phase 3

Completed

• Conditions: Stroke; Circulatory System; Intracerebral haemorrhage

• Registration Number: ISRCTN93732214
• Lead Sponsor: niversity of Nottingham (UK)

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27048694 protocol 2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29431141 sub-study protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29778325 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31322116 results (added 22/07/2019) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31735141 CT results in (added 19/11/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/32902808/ results (added 11/09/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33586453/ results (added 16/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34000834/ (added 19/05/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35311937/ Substudy results (added 22/03/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37337529/ Secondary analysis (added 20/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-17
• Study Completion: 2018-05-31
• Last Update Posted: 4 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2325

Inclusion Criteria

Adult (=18 years, either sex) patients with acute primary intracerebral haemorrhage (PICH) within 8 hours of stroke onset (where stroke onset time is unknown, the time of when last known well will be used)

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 premorbid dependency (mRS>4)
4. Participation in another drug trial concurrently
5. Prestroke life expectancy <3 months (e.g. advanced metastatic cancer)
6. Coma ? Glasgow coma scale <5

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> To assess whether tranexamic acid is safe and reduces death or dependency after primary intracerebral haemorrhage (PICH)<br> Death or dependency (ordinal shift on mRS) at day 90 will be analysed by intention-to-treat using ordinal logistic regression (OLR), with adjustment for minimisation factors. The assumption of proportional odds will be tested using the likelihood ratio test. Comparison of tranexamic acid versus control.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. At day 7 (or discharge if sooner), neurological impairment (NIHSS)<br> 2. At day 90, disability (Barthel index), Quality of Life (EuroQoL), cognition, cognition and mood (TICS and ZDS)<br> 3. Safety: death, serious adverse events, thromboembolic events, seizures<br> 4. Costs: length of stay in hospital, re-admission, institutionalisation<br> 5. Radiological efficacy/safety (CT scan): change in haematoma volume from baseline to 24 hours, haematoma location, and new infarction<br>