Injury (also called trauma) is a leading cause of death for children and young adults. Traumatic brain injury, such as from a blow to the head, is a frequent cause of death for patients with trauma who survive to reach hospital. Approximately half of patients with traumatic brain injury develop bleeding into the brain within the first 48 hours of hospital admission. If bleeding occurs, accumulating blood within the skull can put pressure on the brain and this may be fatal or result in serious long-term disability for the patient. Therefore, drugs that promote the production of clots or reduce the destruction of existing clots (known as haemostatic drugs) might reduce the bleeding into the brain after an injury and thereby reduce the risk of death or disability.
We searched for randomised clinical trials looking at the effectiveness of haemostatic drugs for reducing mortality and disability in patients with traumatic brain injury. We found two studies that evaluated the effects of a type of haemostatic drug called recombined activated factor VII. We reviewed the data presented in the reports of these trials. Both trials were too small to confirm or refute any plausible clinical effect, so we were unable to reach any conclusions regarding the effectiveness of haemostatic drugs for traumatic brain injury patients. More trials are needed to answer this question. Future trials should be large enough to detect plausible and important clinical effects.