PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)

Brief Summary

This is a phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).

Inclusion Criteria

All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:

1. Known Hypersensitivity to FRAGMIN (Dalteparin), or its constituents including benzyl alcohol or to other low molecular weight heparins and/or heparins or pork products
2. Known history of confirmed or suspected immunologically-mediated heparin-induced thrombocytopenia (delayed-onset severe thrombocytopenia), and/or in patients with a known history of a positive in vitro platelet-aggregation test in the presence of FRAGMIN (Dalteparin) is positive
3. Known septic endocarditis
4. Uncontrollable active bleeding
5. Known major blood clotting disorders
6. Known acute gastroduodenal ulcer (with active bleeding)
7. Severe uncontrolled hypertension (i.e. BP>210 despite medications)
8. Known diabetic or hemorrhagic retinopathy
9. Anticipated to be unable to receive SCD on at least one lower extremity due to nature of injuries for duration of intervention period
10. Presence of another confounding factor that can adequately explain the poor GCS at time of presentation (e.g. drug toxicity, seizure)
11. Known presence of irreversible coagulopathies
12. Known Pregnancy
13. Participants extremely low weight (\<45 kg), or extremely high weight (\>120kg)
14. Not expected to survive more than 48 hours from admission