Tranexamic Acid for the treatment of significant traumatic brain injury: an international, randomised, double blind, placebo controlled trial. - CRASH-3 [Version 1.0]
- Conditions
- Traumatic Brain InjuryMedDRA version: 16.1Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2011-003669-14-IT
- Lead Sponsor
- ondon School Of Hygiene and Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12737
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
• 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method