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

Because the coagulation abnormalities that occur after injury are similar to those after surgery, it is possible that antifibrinolytic agents might also reduce blood loss, the need for transfusion and mortality following trauma. However, to date there has been only one small randomised controlled trial (70 randomised patients, drug versus placebo: 0 versus 3 deaths) of the effect of antifibrinolytic agents in major trauma. As a result, there is insufficient evidence to either support or refute a clinically important treatment effect. Systemic antifibrinolytic agents have been used in the management of eye injuries where there is some evidence that they reduce the rate of secondary haemorrhage.. CRASH2 aims to determine the effect of the early administration of the antifibrinolytic agent tranexamic acid (TXA) on death and transfusion requirement in adult trauma patients with ongoing significant haemorrhage, or who are considered to be at risk of significant haemorrhage. In addition, the effect on the risk of non-fatal vascular events (either haemorrhagic or occlusive) will be assessed.. The initial stages of the trial was funded by the London School of Hygiene, the Bupa Foundation and the Moulton Charitable Trust. In 2007, this trial obtained main funding from the NIHR Health Technology Assessment Programme, which will fund this trial from April 2007 to September 2010.. More information on the CRASH2 trial can be found at:. As of 16/06/2008, the CRASH2 trial will conduct sub-group analyses \"CRASH-2 Intracranial Bleeding Study (IBS)\" (start date: October 2009) to study the effect of TXA in participants who also have traumatic brain injury (TBI). About 40% of participants out of 9,000 enrolled so far have TBI. Details of this sub-study can be found at:. Hypothesis: Early administration of TXA can prevent the occurrence or increase of intracranial bleeding in patients with TBI and significant bleeding.. On 21/08/2009 the anticipated start and end dates of this trial were changed from 01/05/2005 and 30/04/2010 to 01/04/2007 and 30/09/2010, respectively.. This trial completed follow-up on the 02/03/2010, and the record was updated to reflect this on 09/07/2010.