RecruitingPhase 3NCT03559114
PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)
PROTEST Trial - PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury, a Double-blind Randomized Controlled Trial
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
1,100 participants
Start Date
Jul 19, 2018
Study Type
INTERVENTIONAL
Conditions
Summary
This is a phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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:
- Requiring invasive mechanical ventilation at the time of screening
- 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 Criteria14
- i) Known Hypersensitivity to FRAGMIN (Dalteparin), or its constituents including benzyl alcohol or to other low molecular weight heparins and/or heparins or pork products
- ii) 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
- iii) Known septic endocarditis
- iv) Uncontrollable active bleeding
- v) Known major blood clotting disorders
- vi) Known acute gastroduodenal ulcer (with active bleeding)
- vii) Severe uncontrolled hypertension (i.e. BP>210 despite medications)
- viii) Known diabetic or hemorrhagic retinopathy
- ix) Anticipated to be unable to receive SCD on at least one lower extremity due to nature of injuries for duration of intervention period
- x) Presence of another confounding factor that can adequately explain the poor GCS at time of presentation (e.g. drug toxicity, seizure)
- xi) Known presence of irreversible coagulopathies
- xii) Known Pregnancy
- xiii) Participants extremely low weight (<45 kg), or extremely high weight (>120kg)
- xiv) Not expected to survive more than 48 hours from admission
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Interventions
DRUGDalteparin
Dalteparin in prophylactic doses administered daily if screening criteria are satisfied.
DRUGSaline
Saline in prophylactic doses administered daily if screening criteria are satisfied.
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03559114
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