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Global trial is first clear evidence that widely available drug reduces head injury deaths

 
Global trial is first clear evidence that widely available drug reduces head injury deaths

A low cost and widely available drug could reduce deaths in traumatic brain injury (TBI) patients by as much as 20%, depending on the severity of injury, a major global study funded by NIHR has found.

Researchers at the London School of Hygiene & Tropical Medicine (LSHTM) say that tranexamic acid (TXA), a drug that prevents bleeding into the brain by inhibiting blood clot breakdown, has the potential to save hundreds of thousands of lives worldwide.

Findings from the CRASH-3 (Clinical Randomisation of an Antifbrinolytic in Significant Head Injury) trial are now published in the Lancet.

The trial is the largest of its kind and involved more than 12,000 head injury patients recruited from 175 hospitals across 29 countries, who were given either intravenous TXA or a placebo.

Researchers found administrating TXA within three hours of injury reduced the number of deaths, with the greatest effect in patients with mild and moderate TBI - leading to a 20% reduction in deaths. No clear benefit was seen in the most severely injured patients. Researchers also found no evidence of adverse effects and no increase in disability in survivors when the drug was used.

TBI is a leading cause of death and disability worldwide with an estimated 69 million new cases each year.

Bleeding in or around the brain due to tearing of blood vessels is a common complication of TBI and can lead to brain compression and death. Although patients with very severe head injuries are unlikely to benefit from TXA treatment because they often have extensive brain bleeding prior to hospital admission and treatment, the study found a substantial benefit in patients with less severe injuries who comprise the majority (over 90%) of TBI cases.



Ian Roberts, Professor of Clinical Trials at LSHTM, said: “We already know that rapid administration of TXA can save lives in patients with life threatening bleeding in the chest or abdomen such as we often see in victims of traffic crashes, shootings or stabbings. This hugely exciting new result shows that early treatment with TXA also cuts deaths from head injury. It’s an important breakthrough and the first neuroprotective drug for patients with head injury.

“We believe that if our findings are widely implemented they will boost the chances of people surviving head injuries in both high income and low income countries around the world.”

Because TXA prevents bleeds from getting worse, but cannot undo damage already done, early treatment is critical. The trial data showed a 10% reduction in treatment effectiveness for every 20-minute delay, suggesting that patients should be treated with TXA as soon as possible after head injury.

The study was jointly funded by the NIHR’s Health Technology Assessment (HTA) Programme, the Department for International Development (DFID), the Medical Research Council (MRC) and Wellcome. The NIHR’s Clinical Research Network (CRN) Trauma and Emergency Care specialty supported UK recruitment to the study and exceeded targets by recruiting 3,143 participants onto the study across 55 UK sites.

Professor Hywel Williams, Director of the HTA Programme, said: “The research team are to be congratulated for delivering a really important study which could benefit millions of people over the world with TBI. The study suggests that TXA is safe in such circumstances and that early administration reduces head injury deaths without increasing disability.

“This study, which has been the largest of its kind, provides high quality evidence that can be used by those planning and providing NHS services.”

CRASH-3 follows successful previous research involving 20,000 trauma patients, which showed that TXA reduced deaths due to bleeding outside of the skull by almost a third if given within three hours. Based on those trial results, TXA was included in guidelines for the pre-hospital care of trauma patients. However, patients with isolated TBI were specifically excluded.

More information on CRASH-3 is available on the NIHR Funding Awards website.

Professor Ian Roberts and colleague Professor Haleema Shakur-Still write about how global collaboration was key to the success of CRASH-3 in their blog on the NIHR website.