PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)
PROTEST
PROTEST Trial - PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury, a Double-blind Randomized Controlled Trial
1 other identifier
interventional
1,100
1 country
12
Brief Summary
This is a phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2018
Longer than P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedStudy Start
First participant enrolled
July 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
September 19, 2024
May 1, 2024
8.4 years
April 10, 2018
September 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinically important VTE
Composite outcome of clinically-important VTE within 7±1 days after randomization defined as any of: 1. Symptomatic, objectively-confirmed pulmonary embolism (PE), or 2. Symptomatic, objectively-confirmed, proximal leg deep vein thrombosis (DVT), or 3. Proximal (above knee) leg DVT on compression ultrasonography on Day 7±1
8 days
Secondary Outcomes (10)
Clinically-important ICB (Intracranial bleeding) progression
7 days
Objectively confirmed new or progressing ICB on radiology,
8 days
180-day Mortality
180 days
7-day Mortality
7 days
30-day Mortality
30 days
- +5 more secondary outcomes
Study Arms (2)
Anticoagulant
ACTIVE COMPARATORDalteparin sodium (at a dose of 5000 IU once daily by subcutaneous injection) for 7 days upon randomization after hospital admission.
Saline
PLACEBO COMPARATORSaline (0.2 mL) once daily by subcutaneous injection for 7 days upon randomization after hospital admission.
Interventions
Dalteparin in prophylactic doses administered daily if screening criteria are satisfied.
Saline in prophylactic doses administered daily if screening criteria are satisfied.
Eligibility Criteria
You may qualify if:
- 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:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Sunnybrook Research Institutecollaborator
Study Sites (12)
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, L8N 3Z5, Canada
Kingston General Hospital
Kingston, Ontario, K7N 2V7, Canada
The Ottawa Hospital
Ottawa, Ontario, KIH 8L6, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5, Canada
Unity Health Toronto
Toronto, Ontario, M5B1W8, Canada
Hopital de L'Enfant-Jesus
Québec, Quebec, G1J 1Z4, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Related Publications (1)
Pirouzmand F, Mathieu F, Mansouri A, Kavikondala K, Alkins R, Boyd JG, Christie S, Couillard P, Cusimano MD, Engels PT, English S, Fourney D, Fowler R, Geerts W, Gooderham PA, Griesdale D, Hunter G, Jabehdar Maralani P, Kelly ME, Klein G, Kramer AH, Kromm J, Kutsogiannis DJ, Lauzier F, Machnowska M, Maslove DM, Mejia-Mantilla J, Midha R, Misra B, Murphy L, O'Kelly CJ, Patel C, Pinto RL, Pronovost AP, Sekhon M, Sharma SV, Sinclair J, Tsai E, Turgeon AF, Warade A, Scales DC; PROTEST investigators. Prophylaxis for venous thromboembolism in traumatic brain injury: protocol for a randomised controlled trial. BMJ Open. 2025 Dec 25;15(12):e114158. doi: 10.1136/bmjopen-2025-114158.
PMID: 41453781DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Farhad Pirouzmand, MD, MSc, FRCSC
Sunnybrook Health Sciences Centre
- PRINCIPAL INVESTIGATOR
Damon Scales, MD, PhD, FRCPC
Sunnybrook Health Sciences Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2018
First Posted
June 15, 2018
Study Start
July 19, 2018
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
September 19, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share