Landmark study shines new light on drug for trauma care

Publication date
Wednesday, 14 Jun 2023
Body
Ambulance workers at an accident

Tranexamic acid is commonly used to limit bleeding during surgery, but its usefulness in emergency settings as a pre-emptive strike in life-threatening bleeding is controversial. Recent studies have provided contradictory results about whether or not tranexamic acid saves lives in advanced trauma systems and whether it might cause side effects such as dangerous blood clotting.

The Pre-hospital Antifibrinolytics for Traumatic Coagulopathy and Haemorrhage (PATCH-Trauma) Study that has just been published in the New England Journal of Medicine shines new light on the drug. Led by Professor Russell Gruen, Dean of the College of Health and Medicine at the Australian National University, along with Monash University’s Intensive Care Research Centre and the Australian and New Zealand Intensive Care Society Clinical Trials Group, it is one of the largest clinical trials ever conducted where treatment to control bleeding was given at the roadside, in an ambulance or in a helicopter prior to reaching hospital. It involved 1310 severely injured patients treated by 15 ambulance services and 21 trauma centres in Australia, New Zealand, and Germany and took eight years to complete.

In addition to the usual care, patients were randomly assigned to receive prehospital tranexamic acid or an inactive placebo. The results showed that for every 100 patients allocated to receive tranexamic acid, there were approximately four extra survivors at six months, but they appeared to be all severely disabled and require a high degree of attendant care.

Professor Gruen described the study as a landmark in trauma care.

“It shows it’s not enough to find out only whether treatments save lives or not – quality of life and the long-term outcomes of care need to be considered too,” he said.

Monash University Professor Stephen Bernard, Medical Advisor to Ambulance Victoria and lead for the Australian arm of the study, praised the ambulance services involved. 

“The PATCH-Trauma Study is further proof that ambulance professionals can conduct rigorous clinical trials in very sick patients and in extremely challenging circumstances,” he noted.

As to whether tranexamic acid should be used for trauma patients, Professor Gruen is circumspect.

"People will have different views on whether surviving with severe disability is better than not surviving at all,” he said.

“Because the drug needs to be given before severely injured patients can make an informed decision, further work is needed to see if there is any way to identify patients who are more likely to survive with a favourable functional outcome if they are given tranexamic acid.

“However, the PATCH-Trauma Study gives us confidence that critical care is possible well before patients get to hospital.”

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