Tranexamic Acid for the treatment of significant traumatic head injury - CRASH-3

Phase 1

• Conditions: Traumatic Brain Injury; MedDRA version: 14.1 Level: LLT Classification code 10060690 Term: Traumatic brain injury System Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2011-003669-14-ES
• Lead Sponsor: ondon School Of Hygiene and Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-12
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10000

Inclusion Criteria

Adult (16 years and older) with traumatic brain injury (TBI)
? who are within 8 hours of injury
? with any intracranial bleeding on CT scan OR GCS ?12 if no scan available, and
? who have no significant extra cranial bleeding (needing immediate blood transfusion)
? The fundamental eligibility criterion is the responsible clinician?s ?uncertainty? as to whether or not to use tranexamic acid in a particular patient with TBI
Are the trial subjects under 18? yes
Number of subjects for this age range: 1000
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

? Patients should not be randomised if the responsible clinician considers there is a clear indication for antifibrinolytic therapy
? Patients should not be randomised if the responsible clinician considers there is a clear contraindication for antifibrinolytic therapy

Study & Design

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