Tranexamic acid for very early bleeds in the brai

Phase 3

• Conditions: Hyperacute primary intracerebral haemorrhage (stroke); Circulatory System; Intracerebral haemorrhage

• Registration Number: ISRCTN97695350
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-21
• Last Update Posted: 9 September 2024
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 5500

Inclusion Criteria

Adult patients with ICH confirmed on brain imaging within 4.5 hours of symptom onset

Exclusion Criteria

Current participant exclusion criteria as of 01/03/2023:
1. Patient with a known indication for TXA treatment (e.g. traumatic brain injury)
2. Patient with contraindication for TXA treatment
3. Patient known to be taking therapeutic anticoagulation with warfarin or low molecular weight heparin at the time of enrolment. Patients taking direct oral anticoagulants can be included and are not excluded.
4. Massive ICH for which haemostatic treatment seems futile (This would ordinarily be when haematoma volume is estimated as larger than 60ml)
5. Severe coma (Glasgow Coma Scale <5)
6. Decision was already taken for palliative (end of life) care with the withdrawal of active treatment

Previous participant exclusion criteria:
1. Indication for TXA
2. Patient known to be taking anti-coagulation
3. Glasgow Coma Scale (GCS) <5
4. Estimated haematoma volume (HV) >60 ml
5. Palliative care

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death at 7 days, measured by the number of participants who have died by Day 7

Secondary Outcome Measures

Name	Time	Method
1. Disability measured by modified Rankin Scale (mRS) at Day 180<br>2. Venous thromboembolism/ischaemic events/seizures measured by review of medical notes at Day 7<br>3. Quality of life measured by EQ-5D visual analogue score (VAS) at Day 180<br>4. Cognition measured by AD-8 at Day 180<br>5. Health economics (use of antihypertensive medication, Do Not Resuscitate orders, admission to intensive care, neurosurgical intervention, hospital length of stay and discharge disposition) measured by review of medical notes at Day 180