NCT03559114 PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)
| NCT ID | NCT03559114 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2018-07-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,100 participants in total. It began in 2018-07-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).
Eligibility 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
Contact & Investigator
Farhad Pirouzmand, MD, MSc, FRCSC
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT03559114 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03559114 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,100 participants.
Is NCT03559114 currently recruiting?
Yes, NCT03559114 is actively recruiting participants. Contact the research team at farhad.pirouzmand@sunnybrook.ca for enrollment information.
Where is the NCT03559114 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Edmonton, Canada, Vancouver, Canada and 8 additional locations.
Who is sponsoring the NCT03559114 clinical trial?
NCT03559114 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Farhad Pirouzmand, MD, MSc, FRCSC at Sunnybrook Health Sciences Centre. The trial plans to enroll 1,100 participants.