Preventing blood clots in patients with severe traumatic brain injury
PROTEST Trial - PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury, a Double-blind Randomized Controlled Trial
This study is testing whether using a combination of special leg devices and blood thinners can better prevent blood clots in people with severe brain injuries without causing more bleeding in the brain.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 12 sites (Calgary, Alberta and 11 other locations) |
| Trial ID | NCT03559114 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with severe or moderate traumatic brain injury requiring intensive care.
Not a fit: Patients with known hypersensitivity to the anticoagulant Dalteparin or its components will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of blood clots in patients with severe TBI, improving overall patient outcomes.
How similar studies have performed: Other studies have shown success with similar approaches in preventing VTE in hospitalized patients, but this specific combination in TBI patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Calgary, Alberta and 11 other locations
- 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)
- Kingston General Hospital — Kingston, Ontario, Canada (Recruiting)
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- Sunnybrook Health Science Centre — Toronto, Ontario, Canada (Recruiting)
- Unity Health Toronto — Toronto, Ontario, Canada (Recruiting)
- Hopital de L'Enfant-Jesus — Québec, Quebec, Canada (Recruiting)
- Royal University Hospital — Saskatoon, Saskatchewan, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.