Preventing blood clots in patients with severe traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III, multi-centre, double-blind, randomized controlled trial focuses on patients with severe traumatic brain injury (TBI) who are at risk for developing venous thromboembolism (VTE). The study compares the effectiveness of using sequential compression devices (SCDs) alone versus a combination of SCDs and anticoagulants in preventing blood clots without increasing the risk of brain bleeding. By including a broad range of patients with varying degrees of TBI, the study aims to provide valuable insights into optimal prophylactic strategies for this vulnerable population.

Why it matters

Who can join: the full rules

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 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's running

• Foothills Medical Centre
  Calgary, Alberta, Canada Recruiting
• Royal Alexandra Hospital
  Edmonton, Alberta, Canada Recruiting
• University of Alberta Hospital
  Edmonton, Alberta, Canada Recruiting
• Vancouver General Hospital
  Vancouver, British Columbia, Canada Recruiting
• Queen Elizabeth II Health Sciences Centre
  Halifax, Nova Scotia, Canada Recruiting
• Hamilton Health Sciences Centre
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Farhad Pirouzmand, MD, MSc, FRCSC — Sunnybrook Health Sciences Centre
• Study coordinator: Farhad Pirouzmand, MD, MSc, FRCSC
• Email: farhad.pirouzmand@sunnybrook.ca
• Phone: 416-480-6100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.