PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)
Trial Parameters
Brief Summary
This is a phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).
Eligibility Criteria
Inclusion Criteria The pragmatic nature of this study seeks to include all consecutive patients presenting with significant TBI, regardless of whether ICB is evident at presentation. Inclusion criteria are the following: i) Patients with severe TBI defined as GCS of ≤8, or ii) Patients with moderate TBI defined as GCS = 9-12, admitted to ICU, with at least some ICB present on initial CT scan and any of the following: 1. Requiring invasive mechanical ventilation at the time of screening 2. Increased ICB on repeat CT scan compared to initial CT scan iii) Upon randomization the patient will be able to receive the first dose of study drug in the first 3 calendar days from the time of injury iv) ≥ 18 years of age Exclusion Criteria All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study: i) Known Hypersensitivity to FRAGMIN (Dalteparin), or its constituents including benzyl alcohol or to other low molecular weight hepari