Traumatic Brain Injury study: Dalteparin vs Saline
Official title PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)
ClinicalTrials.gov ID: NCT03559114
What this study is testing
What is Dalteparin?
This is an investigational blood-thinning medicine being studied to help prevent blood clots in patients with traumatic brain injury. It is designed to thin the blood to make it harder for clots to form.
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
- The study aims to find out if a specific blood thinner safely prevents blood clots in patients with severe traumatic brain injury.
- Who it's for
- The study is looking for adults who have suffered a severe traumatic brain injury.
- What's involved
- Participants will receive either a blood-thinning medication or a placebo (a pill with no active ingredient) and be monitored for blood clots and bleeding.
- Time commitment
- The source text does not specify the duration or visit schedule for this study.
- 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
- 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
- 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
- vi) Known acute gastroduodenal ulcer (with active bleeding)
See the full eligibility criteria
- 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...
- 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 is enrolling
- 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
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.