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New treatment option for Traumatic Brain Injury
Official title PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)
ClinicalTrials.gov ID: NCT03559114
What this study is testing
What is Dalteparin?
Dalteparin is an investigational medicine, given as an once-daily, being studied as a potential treatment for traumatic brain injury.
Also referred to as Fragmin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The pragmatic nature of this study seeks to include all consecutive patients presenting with significant TBI, regardless of whether ICB is evident at...
- 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...
You likely can't join if
- 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...
- ii) Known history of confirmed or suspected immunologically-mediated heparin-induced thrombocytopenia (delayed-onset severe thrombocytopenia), and/or...
- iii) Known septic endocarditis
- iv) Uncontrollable active bleeding
- v) Known major blood clotting disorders
See the full eligibility 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. are the following: i) Patients with severe TBI defined...
- 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...
- 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...
- 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 (\ 120kg)
- xiv) Not expected to survive more than 48 hours from admission
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Québec, Quebec, Canada
- Saskatoon, Saskatchewan, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.