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

Ki vehet részt

• 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:
• Patients with severe TBI defined as GCS of ≤8, or
• 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:
• Requiring invasive mechanical ventilation at the time of screening
• Increased ICB on repeat CT scan compared to initial CT scan
• 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
• ≥ 18 years of age

Ki nem vehet részt

• Known Hypersensitivity to FRAGMIN (Dalteparin), or its constituents including benzyl alcohol or to other low molecular weight heparins and/or heparins or pork products
• Uncontrollable active bleeding
• Known major blood clotting disorders
• Known acute gastroduodenal ulcer (with active bleeding)
• Severe uncontrolled hypertension (i.e. BP>210 despite medications)
• Presence of another confounding factor that can adequately explain the poor GCS at time of presentation (e.g. drug toxicity, seizure)
• 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
• All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
• Known septic endocarditis
• Known diabetic or hemorrhagic retinopathy
• Anticipated to be unable to receive SCD on at least one lower extremity due to nature of injuries for duration of intervention period
• Known presence of irreversible coagulopathies
• Known Pregnancy
• Participants extremely low weight (<45 kg), or extremely high weight (>120kg)
• Not expected to survive more than 48 hours from admission