Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
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 requirements. Adults with trauma who are within 8 hours 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. Numbered drug or placebo packs will be available in each
participating emergency department. Randomisation will involve calling a 24-hour freecall
randomisation service. The call should last only a minute or two and at the end of it the
randomisation service will specify which numbered treatment pack to use. For hospitals where
telephone randomisation is not feasible, randomisation will be by taking the next
consecutively numbered treatment pack. No extra tests are required but a short form must be
completed one month later or on discharge or on death (whichever occurs first).