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

Recruiting now · Phase 3

Conditions studied: Traumatic Brain Injury

In brief

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

Key facts

Study ID

NCT03559114

Run by

Sunnybrook Health Sciences Centre

People needed

1100

Starts

2018-07-19

Expected to finish

2027-12-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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

You may not qualify if…

• 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 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

Where it is running

• Foothills Medical Centre — Calgary, Alberta, Canada (enrolling)
• Royal Alexandra Hospital — Edmonton, Alberta, Canada (enrolling)
• University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
• Vancouver General Hospital — Vancouver, British Columbia, Canada (enrolling)
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada (enrolling)
• Hamilton Health Sciences Centre — Hamilton, Ontario, Canada (enrolling)
• Kingston General Hospital — Kingston, Ontario, Canada (enrolling)
• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• Sunnybrook Health Science Centre — Toronto, Ontario, Canada (enrolling)
• Unity Health Toronto — Toronto, Ontario, Canada (enrolling)
• Hopital de L'Enfant-Jesus — Québec, Quebec, Canada (enrolling)
• Royal University Hospital — Saskatoon, Saskatchewan, Canada (enrolling)

Full record on ClinicalTrials.gov

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