Status:
COMPLETED
Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Conditions:
Hemorrhage
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
CRASH 2 is a large pragmatic randomised placebo controlled trial of the effects of the early administration of the antifibrinolytic agent tranexamic acid on death, vascular events and transfusion requ...
Detailed Description
See trial website for full protocol. This is an international trial with over 300 hospitals in about 40 countries worldwide.
Eligibility Criteria
Inclusion
- All trauma patients with ongoing significant haemorrhage (systolic blood pressure less than 90 mmHg and/or heart rate more than 110 beats per minute), or who are considered to be at risk of significant haemorrhage, and are within 8 hours of the injury, are eligible for trial entry if they appear to be at least 16 years old. Although entry is allowed up to 8 hours from injury, the earlier that patients can be treated the better.
Exclusion
- The fundamental eligibility criterion is the responsible doctor's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular adult with traumatic haemorrhage. Patients for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised. Likewise, patients for whom there is considered to be a clear contraindication to antifibrinolytic therapy (such as, perhaps, those who have clinical evidence of a thrombotic disseminated intravascular coagulation) should not be randomised. Where the responsible doctor is substantially uncertain as to whether or not to use an antifibrinolytic, all these patients are eligible for randomisation and should be considered for the trial. There are no other pre-specified exclusion criteria
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
20211 Patients enrolled
Trial Details
Trial ID
NCT00375258
Start Date
May 1 2005
End Date
March 1 2010
Last Update
June 30 2011
Active Locations (1)
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1
Over 50 countries Worldwide
London, United Kingdom