CompletedHeart, Stroke & BloodPregnancy, Children & Inherited Conditions
CRASH2 Trial, a large randomised placebo controlled trial among trauma patients with significant haemorrhage of the effects of an antifibrinolytic treatment on death and transfusion requirement
Tranexamic acid, a cheap drug that prevents blood clots from breaking down, is being tested against a placebo in thousands of trauma patients who are bleeding heavily or at risk of doing so. Uncontrolled bleeding after injury kills many people worldwide, yet there is no simple, widely practicable drug proven to reduce those deaths. The CRASH-2 trial aims to fill that gap by testing whether giving tranexamic acid early—within eight hours of injury—can improve survival and reduce the need for blood transfusions. The trial is large enough to detect even a small survival advantage, because even a modest benefit from such a simple intervention would be worthwhile. If the drug works, it could change emergency trauma care globally. Tranexamic acid is inexpensive, stable, and easy to administer, so it could be used in ambulances, field hospitals, and low-resource settings where advanced surgical options are limited. The trial also tracks side effects such as strokes and clots, ensuring that any survival benefit is not offset by harm. The results could quietly reshape how bleeding is managed in accidents, violence, and disasters—systems most people never think about until they need them.
View original technical description
The CRASH 2 trial is a randomised placebo-controlled trial of the effects of the early administration of the antifibrinolytic agent tranexamic acid on death, vascular events, and transfusion requirements. Adults with trauma who are within 8 h of injury and have either significant haemorrhage, or who are considered to be at risk of significant haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Randomisation will involve calling a 24-h free-call randomisation service. For hospitals where telephone randomisation is not feasible, randomisation will be by taking the next consecutively numbered blinded treatment pack. Because even a 2% survival advantage for an intervention as simple and widely practicable as tranexamic acid would represent a worthwhile benefit, CRASH-2 has been planned to be able to detect a benefit of this size. If the real mortality difference is 20% versus 18%, then there is about an 85% chance that a trial involving 20 000 patients will achieve 2P<0.01 (and a 95% chance that it will achieve 2P<0.05). The primary outcome measure is death in hospital within 4 weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). Secondary outcome measures: receipt of a blood-products transfusion, the number of units of blood products transfused, surgical intervention, and the occurrence of thromboembolic episodes (stroke, myocardial infarction, pulmonary embolism, clinical evidence of deep vein thrombosis). Comparisons will be made of the primary outcome measure, comparing all those allocated antifibrinolytic treatment versus those allocated placebo, on an intention-to-treat basis. Analyses will be stratified on time from injury to the start of treatment (less than 1h, 1-3h, more than 3h), on severity of haemorrhage as assessed by capillary refill time (0-2, 3-4, >5 s), and systolic blood pressure ( 89 mm Hg).
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