Timing Of venous thromboembolism Prophylaxis for adult patients with Traumatic Brain Injury (TOP-TBl): a pragmatic, randomised trial
Medical condition: Traumatic Brain Injury (TBI) Medical condition in lay language: Severe brain injury following an accident Therapeutic areas: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
Early pharmacologic thromboprophylaxis (PTP) arm - defined as administration of PTP within 72 hours of TBI Late PTP arm - defined as administration of PTP after a minimum of 120 hours from TBI or PTP not administered at clinical discretion. · IMP o Low molecular weight heparin (LMWH), o Low molecular weight sulphated glycosaminoglycuronans o DOAC (Direct Oral Anticoagulants) o Synthetic pentasaccharide o Heparin The dose, dose frequency, and route of administration to be used are at the discretion of the doctor managing patient care using NICE guidelines. Sealed Envelopes will be used for the randomisation.
1. Adult patients (≥16 years of age) 2. Acute TBI (defined as acute traumatic changes on CT brain, either in isolation or in the context of polytrauma) 3. Patients admitted to hospital within 72 hours of injury
1. Patients with recent Venous Thromboembolism (VTE) - within 3 months before TBI 2. Known hypersensitivity to any VTE prophylaxis agents to be used in this trial 3. Patients not expected to live beyond 72 hours 4. Time interval from injury to randomisation exceeding 72 hours 5. Participation in the same study within last 12 months 6. Current use of anticoagulation for an alternative indication, with a clinical decision to continue 7. Acute bleeding deemed serious enough that the treating clinical team lack equipoise for the study question 8. Progression of early traumatic intracranial haemorrhage or unstable neurological condition, such that the treating clinical team lack equipoise for the study questions