Actively Recruiting
PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)
Led by Sunnybrook Health Sciences Centre · Updated on 2024-09-19
1100
Participants Needed
12
Research Sites
488 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
S
Sunnybrook Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).
CONDITIONS
Official Title
PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with severe traumatic brain injury defined as Glasgow Coma Scale (GCS) of 8 or less
- Patients with moderate traumatic brain injury defined as GCS 9-12, admitted to ICU, with some intracranial bleeding on initial CT scan and at least one of: requiring invasive mechanical ventilation or increased intracranial bleeding on repeat CT scan
- Able to receive the first dose of study drug within 3 calendar days of injury
- At least 18 years of age
You will not qualify if you...
- Known allergy or hypersensitivity to Dalteparin, heparins, or pork products
- History of heparin-induced thrombocytopenia or positive platelet-aggregation test with Dalteparin
- Known septic endocarditis
- Uncontrollable active bleeding
- Known major blood clotting disorders
- Known active gastroduodenal ulcer with bleeding
- Severe uncontrolled high blood pressure (blood pressure over 210 despite medications)
- Known diabetic or hemorrhagic retinopathy
- Unable to receive sequential compression device (SCD) on at least one lower leg due to injury
- Other factors explaining poor Glasgow Coma Scale at presentation (e.g., drug toxicity, seizures)
- Known irreversible blood clotting disorders
- Known pregnancy
- Extremely low weight (under 45 kg) or extremely high weight (over 120 kg)
- Not expected to survive more than 48 hours after admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Actively Recruiting
2
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Actively Recruiting
3
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
4
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
5
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Actively Recruiting
6
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
7
Kingston General Hospital
Kingston, Ontario, Canada, K7N 2V7
Actively Recruiting
8
The Ottawa Hospital
Ottawa, Ontario, Canada, KIH 8L6
Actively Recruiting
9
Sunnybrook Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
10
Unity Health Toronto
Toronto, Ontario, Canada, M5B1W8
Actively Recruiting
11
Hopital de L'Enfant-Jesus
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
12
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Actively Recruiting
Research Team
F
Farhad Pirouzmand, MD, MSc, FRCSC
CONTACT
K
Kanthi Kavikondala, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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