Details of HTA project in progress
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
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 |
 Outputs in journals arising from this project
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Project ref: |
06/303/20 |
Cost: |
£2,513,781 |
Chief Investigator : |
Professor Ian Roberts, Professor of Epidemiology and Public Health, , London School of Hygiene and Tropical Medicine |
Project Website |
http://www.crash2.lshtm.ac.uk/ |
Start Date: |
April 2007 |
Estimated date of publication in HTA journal series: |
Mid 2012. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
About half of trauma patients who survive to reach hospital die because of blood loss. Tranexamic acid is a treatment that helps clotting by preventing clot breakdown. It is widely used in major surgery because it is effective in reducing blood loss and the need for blood transfusion. However, it has never been tested in trauma patients. If it was also shown to reduce blood loss after major trauma then this might prevent many thousands of trauma deaths world-wide and would also avoid exposing patients to the risks of blood transfusion. To date, there have been no clinical trials of tranexamic acid in trauma. We will conduct a very large trial (20,000 patients) of tranexamic acid in trauma to see if it reduces trauma deaths and the need for blood transfusion. The trial will be conducted in around 400 emergency departments in hospitals world-wide. Adult trauma patients (aged 16 years or older) who are within 8 hours of their injury and have significant bleeding will be randomly allocated to recieve either tranexamic acid or matching placebo. At the end of the trial we will compare mortality, quality of survival and the transfusion requirments in the two groups. The trial has multi-centre research ethics committee approval for the UK and will be approved by the ethics committees of all participating hospitals before recruitment can take place. The trial team are experienced in conducting large trials in trauma care having previously conducted a very large trial of a treatment for head injury (over 10,000 patients). Over the past year we have conducted a pilot phase to test out all the trial procedures and to see if large numbers of patients could be recruited. The pilot phase was a success with over 2,000 patients randomised. There is huge interest in the trial from doctors around the world and hundreds of hospitals have applied to take part. The trial has the support of the World Health Organisation because trauma is a common cause of death world-wide, because blood transfusion can transmit HIV and hepatitis infection and because tranexamic acid is not expensive and so could be made widely available. The trial also has the support of the Ministry of Defence because bleeding is the leading cause of death among soldiers in combat situations. Tranexamic acid is light and heat stable and could easily be used in such situations. |
Project Abstract: |
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 (<75, 76-89, >89 mm Hg). |
NRR* number, if applicable: |
N0484193519 (*National Research Register). The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS). It is now an archive of projects from early 2000 to September 2007. Search the NRR archive. |
ISRCTN* number: | ISRCTN 86750102 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN86750102 |
Project Protocol: |
Project protocol (pdf format, 1141 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1604 |
Outputs from this project |
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