A traumatic brain injury (TBI) is a brain injury that occurs when an external force causes damage to the head. These injuries are common and are usually caused by falls, assaults, road traffic accidents and mishaps at home etc. Suffering a TBI increases your chance of developing blood clots in your veins (VTEs). These VTEs complicate recovery from TBI, lead to long-term reductions in quality of life, and can occasionally be fatal. Doctors typically start blood thinning medication to reduce the chances of blood clots forming in patients who have suffered a TBI, as evidence suggests that it can improve patients’ long-term function outlook and quality of life.

National UK guidelines recommend starting blood thinning medication within 14 hours of hospital admission, and this has significantly reduced the number of deaths due to VTE during the hospital stay and up to 90 days from discharge. However, some doctors worry that blood thinning medication could increase the risk of further bleeding in the brain, especially soon after injury. This leads to some doctors withholding blood thinning medications from TBI patients for a prolonged period of time (e.g., 5 days). However, studies following TBI patients over a period of time found that those who had received blood thinning medication within 72 hours did not have an increased risk of further bleeding compared to those who received it later. This leads to other doctors starting blood thinning medication for TBI patients within 72 hours of injury.

This study is designed to compare the timing of blood thinning medication and to guide the best practices in the future for initiating blood thinning medication to reduce the rate of blood clots, without introducing complications from further bleeding. In this trial, we will be testing the early initiation of blood thinning medications (within 72 hours from injury) to late initiation (deferred by a minimum of 120 hours from injury).

If you agree to take part in the trial, you will be allocated into one of the two study groups. The “early” group will commence blood thinning medication within 72 hours from injury, while the “late” group will have their blood thinning medication deferred by at least 120 hours from injury or not administered as per clinical decision.  Allocation to either “early” or “late” group will be done in a random way by a computer and not by a member of your clinical care team so the chance of being in either group is 50%.  

The rest of the medical treatment and care of patients will not change from usual clinical practice. It is important to understand that the doctor has no influence on whether you are randomised to the “early” group or the “late” group and if you agree to participate it means that you accept the decision to be allocated in either group in a random way. Randomisation is important because it makes sure that every person has an equal chance of being in any of the two groups, and makes the results fair.

You are then followed up with regular assessments and you will be seen by the hospital/ doctor/ care team regularly to have some tests and to see how you are feeling.