International Trauma Trial Could Save Thousands Of Lives, UK

Main Category: Clinical Trials / Drug Trials
Also Included In: Blood / Hematology
Article Date: 04 Oct 2007 - 1:00 PDT

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In a world first, a UK-coordinated clinical trial involving up to 20,000 patients across the globe is testing a new way of stopping blood loss in patients who have suffered a major injury (trauma). Trauma is the second biggest cause of death in young people worldwide, claiming about three million lives each year. The international CRASH-2 trial has been funded by the Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), to examine the clinical and cost-effectiveness of tranexamic acid for treating trauma patients.

Tranexamic acid is a treatment that may minimise bleeding by reducing clot breakdown. It is widely used in major surgery, as it is effective in reducing blood loss and the need for blood transfusion. It is thought that tranexamic acid could be effective for reducing blood loss in trauma patients, but this has never been tested.

Led by Professor Ian Roberts of the London School of Hygiene and Tropical Medicine, the research involves more than 200 hospitals spanning 47 countries, including Iraq, Colombia, Nigeria, Egypt, India and the UK. Patients are given either tranexamic acid or a placebo within eight hours of injury, to see whether the number of deaths in hospital, or the need for blood transfusions, is reduced.

"Road traffic accidents and violence are the biggest causes of trauma, and blood loss from severe injuries received in combat is the leading cause of death in soldiers," says Professor Roberts. "In countries where conflict and violence is high and unsafe blood transfusions are common, this research is crucial.

"Tranexamic acid is a simple and inexpensive treatment, and it is also light and remains stable in hot conditions making it ideal for use across the world. It has the potential to save thousands of lives as well as reducing exposure to the risks of blood transfusion."

So far over 6,000 patients have been recruited to the trial, and the research team hopes to have recruited 20,000 patients to the trial by 2010. "It is important that large numbers of patients are involved in the trial, so that even moderate effects can be measured. Even a small increase in survival would be significant in terms of the number of lives saved," adds Professor Roberts.

1. Tranexamic acid has been provided free by the manufacturer for the clinical trial

2. The CRASH-2 trial is also being supported by the World Health Organisation Blood Transfusion Team, the European Federation of the Victims of Road Traffic Injuries, the Lancet and the MOD.

3. The HTA programme is a programme of the National Institute for Health Research (NIHR) and produces high quality research information about the effectiveness, costs, and broader impact of health technologies for those who use, manage and provide care in the NHS. It is the largest of the NIHR programmes and publishes the results of its research in the Health Technology Assessment journal, with more than 380 issues published to date. The journal's 2006 Impact Factor (5.29) ranked it in the top 10% of medical and health-related journals. All issues are available for download free of charge from the website, http://www.hta.ac.uk The HTA programme is coordinated by the National Coordinating Centre for Health Technology Assessment (NCCHTA), based at the University of Southampton.

4. The National Institute for Health Research, part of the Department of Health, provides the framework through which the research staff and research infrastructure of the NHS in England is positioned, maintained and managed as a national research facility. The NIHR provides the NHS with the support and infrastructure it needs to conduct first-class research funded by the Government and its partners alongside high-quality patient care, education and training. Its aim is to support outstanding individuals (both leaders and collaborators), working in world class facilities (both NHS and university), conducting leading edge research focused on the needs of patients.

http://www.nihr.ac.uk