PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)
NCT ID: NCT03559114
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1100 participants
INTERVENTIONAL
2018-07-19
2027-12-31
Brief Summary
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Detailed Description
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This study will compare results from patients who receive the SCDs only to those who receive both SCD and anticoagulants. The outcome of this study will provide information about how best to prevent blood clots while not increase brain bleeding after head injury.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Anticoagulant
Dalteparin sodium (at a dose of 5000 IU once daily by subcutaneous injection) for 7 days upon randomization after hospital admission.
Dalteparin
Dalteparin in prophylactic doses administered daily if screening criteria are satisfied.
Saline
Saline (0.2 mL) once daily by subcutaneous injection for 7 days upon randomization after hospital admission.
Saline
Saline in prophylactic doses administered daily if screening criteria are satisfied.
Interventions
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Dalteparin
Dalteparin in prophylactic doses administered daily if screening criteria are satisfied.
Saline
Saline in prophylactic doses administered daily if screening criteria are satisfied.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Sunnybrook Research Institute
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Farhad Pirouzmand, MD, MSc, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Damon Scales, MD, PhD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Unity Health Toronto
Toronto, Ontario, Canada
Hopital de L'Enfant-Jesus
Québec, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Andreas Kramer, MD
Role: backup
Jim Kutsogiannis, MD, MHS, FRCPC
Role: backup
Jim Kutsogiannis, MD, MHS, FRCPC
Role: backup
Donald Griesdale, MD, MPH, FRCPC
Role: backup
Sean Christie, MD, FRCSC
Role: backup
Laurel Murphy, MD
Role: backup
Sunjay Sharma, MD, MSc, FRCSC, FACS
Role: backup
Paul Engels, MD
Role: backup
Gordon Boyd, MD, PhD, FRCPC
Role: backup
Shane English, MD, MSc, FRCPC
Role: backup
Farhad Pirouzmand, MD, MSc, FRCSC
Role: primary
Damon Scales, MD, PhD, FRCPC
Role: backup
Michael Cusimano, MD, MHPE, FRCS, PhD
Role: backup
Alexis Turgeon-Fournier, MD
Role: backup
Gary Hunter, MD, FRCPC, CSCN (EEG)
Role: backup
Other Identifiers
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0785
Identifier Type: -
Identifier Source: org_study_id
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