Trauma & surgery trials

Overview

Through our clinical trials spanning over two decades, we have shown that tranexamic acid reduces death in patients with traumatic brain injuries.

Trauma

Each year around the world, nearly six million people die from trauma – many after reaching the hospital.

Among trauma patients who reach hospital, extracranial bleeding is a common cause of death, accounting for around 40% of in-hospital deaths. Extracranial bleeding occurs outside of the brain and is often caused by falls, vehicle accidents, or sports injuries.

The CRASH-2 Trial evaluated the effect of tranexamic acid on death and vascular occlusive events in over 20,000 patients with traumatic bleeding. The trial showed that tranexamic acid significantly reduced mortality in bleeding trauma patients but should be given as early as possible.

Bleeding into the brain, or intracranial haemorrhage is also common following a head injury. As the volume of blood increases, it exerts pressure inside the skull. If the bleeding continues and the pressure continues to rise, compression of the brain leads to oxygen deprivation, brain herniation, and death.

Patients with traumatic brain injuries (TBI) can experience a loss in physical, behavioural, or emotional functioning. Even with rehabilitation, only 40-50% of patients recover completely.

The CRASH-3 Trial assessed the effects of tranexamic acid on death and disability in over 12,000 patients with TBI and showed that the administration of tranexamic to patients with TBI within three hours of injury reduces head injury-related death.

The CRASH-4 Trial aims to provide reliable evidence about the effects of early intramuscular tranexamic acid on intracranial bleeding, disability and death in older adults with head injuries.

A fall from standing height in older adults is the most common cause of major trauma in the UK. As the UK population is steadily ageing, the number of older adults with TBI will continue to rise.

Surgery

Each year, over 300 million people around the world undergo a major surgical procedure, of which around 4 million die within 30 days of the operation. Major bleeding accounts for the largest share of these deaths.

Transfusions can be lifesaving, but blood is a scarce resource and there are transfusion related risks. We have evidence that tranexamic acid reduces both surgical bleeding and the need for transfusion, which has important implications for patient care.

Tranexamic acid has been used for many years in surgery and there is good evidence from randomised controlled trials that it reduces surgical bleeding. Indeed, tranexamic acid is shown to reduce blood loss in surgical patients by about one‐third.

A 2012 systematic review produced strong evidence that tranexamic acid reduces the risk of peri-operative blood transfusion by up to one third, thus also reducing the duration of anaesthesia, the need for intensive care and facilitating early discharge.

A further analysis of data from 50,000 and 100,000 patients also showed that using tranexamic acid did not lead to an increased risk of thrombosis. Although high doses of tranexamic acid can cause seizures, the dose given before an operation is not associated with an increased risk.

Our team continues to advocate for wider use of tranexamic acid in surgery, as a way of reducing patient deaths, as well as the need for blood transfusions.

 

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