| Protocol No: | ECCT/14/10/02 | Date of Protocol: | 01-10-2011 |
| Study Title: | Acronymn: CRASH-3 Short Title: Clinical Randomisation of an Antifibrinolytic in Significant Head Injury Full Title: Tranexamic acid for the treatment of significant traumatic brain injury: an international randomised, double blind placebo controlled trial ISRCTN15088122 ClinicalTrials.gov ID: NCT01402882 |
| Study Objectives: | |
| Laymans Summary: | |
| Abstract of Study: | The problem Worldwide, over 10 million people are killed or hospitalised because of traumatic brain injury (TBI) each year. Approximately 90% of deaths from TBI occur in low and middle income countries. TBI predominantly affects young adults and many patients experience long lasting or permanent disability. The social and economic burden of TBI is considerable. With rapidly increasing motorisation, the incidence of TBI is predicted to rise in low and middle income countries. An effective, widely practicable and affordable treatment for TBI could save many thousands of lives and could substantially reduce the burden of disability. The aim The CRASH-3 trial will provide reliable evidence about the effect of tranexamic acid on mortality and disability in patients with TBI. The effect of TXA on the risk of vascular occlusive events and seizures will also be assessed. The intervention Systemic antifibrinolytic drugs, including tranexamic acid, are widely used in surgery to prevent clot breakdown (fibrinolysis) and thus reduce surgical blood loss. Currently there is insufficient reliable evidence to assess the effectiveness of tranexamic acid traumatic brain injury. This trial would provide a reliable basis for recommending whether or not tranexamic acid should be administered to patients with TBI. The trial The CRASH-3 trial is a large, international, randomised, placebo controlled trial, to quantify the safety and effect on mortality and morbidity of the administration of tranexamic acid in patients with TBI. Adults with TBI, who are within eight hours of injury, with any intracranial bleeding on CT scan or who have a GCS of 12 or less, and have no significant extra-cranial haemorrhage, are eligible for inclusion, except those for whom antifibrinolytic agents are thought to be clearly indicated or clearly contra-indicated. Treatment will be allocated randomly and numbered drug /placebo packs will be available in participating hospitals. The primary outcome will be death in hospital within 28 days of injury (cause of death will be described). Outcomes will be assessed at death, discharge or 28 days after randomisation, whichever occurs first. |