PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    1100
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 25 March 2021
traumatic brain injury
severe traumatic brain injury

Summary

This is a pilot study, phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).

Description

Patients with severe brain injury are at risk for developing blood clots in their legs, which can travel to the lungs. This potentially serious complication is known as venous thromboembolism (VTE). Anticoagulants are commonly used to prevent VTE in hospital patients. However, in patients with major head injury, anticoagulant prevention is commonly delayed for the fear that it can potentially lead to further bleeding in the brain. Another method that aims to prevent blood clots involves the use of sequential compression device (SCD) that compress the legs and increase the flow of blood in the leg veins.

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.

Details
Condition Brain Injury, Traumatic Brain Injury, Brain Injuries, Traumatic, traumatic brain injury (tbi)
Treatment dalteparin, Saline
Clinical Study IdentifierNCT03559114
SponsorSunnybrook Health Sciences Centre
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 16 yrs?
Gender: Male or Female
Do you have any of these conditions: Brain Injuries, Traumatic or Brain Injury or Traumatic Brain Injury?
Do you have any of these conditions: Brain Injuries, Traumatic or traumatic brain injury (tbi) or Traumatic Brain Injury or Brain Injury?
Do you have any of these conditions: Traumatic Brain Injury or Brain Injury or Brain Injuries, Traumatic or traumatic brain injury (tbi)?
Do you have any of these conditions: Traumatic Brain Injury or Brain Injuries, Traumatic or traumatic brain injury (tbi) or Brain Injury?
Patients with severe acute TBI defined as GCS 8 and within 48 hours of injury
years of age (with exception of Quebec where patients will be 18 years of age)

Exclusion Criteria

Known Hypersensitivity to FRAGMIN (Dalteparin), or its constituents including benzyl alcohol or to other low molecular weight heparins and/or heparins or pork products
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
Known septic endocarditis
Uncontrollable active bleeding
Known major blood clotting disorders
Known acute gastroduodenal ulcer (with active bleeding)
Severe uncontrolled hypertension (i.e. BP>210 despite medications)
Known diabetic or hemorrhagic retinopathy
Confirmed complete acute spinal cord injury
Unable to receive bilateral SCDs due to femur fracture, below-knee injury requiring external fixation device, critical lower leg ischemia
Unstable pelvic fracture requiring external or internal fixation
Presence of another confounding factor that can adequately explain the poor GCS at time of presentation (e.g. drug toxicity, seizure)
Known presence of irreversible coagulopathies
Known Pregnancy
Participants extremely low weight (<45 kg), or extremely high weight (>120kg)
Not expected to survive more than 48 hours from admission
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