Status:
COMPLETED
Clinical Randomisation of an Antifibrinolytic in Significant Head Injury
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The CRASH-3 trial will provide reliable evidence about the effect of tranexamic acid on mortality and disability in patients with traumatic brain injury. The effect of tranexamic acid on the risk of v...
Detailed Description
BACKGROUND: Worldwide, over 10 million people are killed or hospitalised because of traumatic brain injury (TBI) each year. About 90% of deaths from TBI occur in low and middle income countries. TBI m...
Eligibility Criteria
Inclusion
- Adults with traumatic brain injury who
- are within eight hours of injury (limited to within 3 hours from September, 2016)
- with any intracranial bleeding on CT scan or who have a GCS of 12 or less, and
- have no significant extra-cranial haemorrhage The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use tranexamic acid in a particular patient with traumatic brain injury
Exclusion
- The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use tranexamic acid in a particular patient with traumatic brain injury
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
12737 Patients enrolled
Trial Details
Trial ID
NCT01402882
Start Date
July 1 2012
End Date
October 1 2019
Last Update
February 17 2020
Active Locations (1)
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1
High Technology Medical Center, University Clinic
Tbilisi, Georgia