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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    1100
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 16 February 2022
subarachnoid hemorrhage
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 Traumatic Brain Injury
Treatment dalteparin, Saline
Clinical Study IdentifierNCT03559114
SponsorSunnybrook Health Sciences Centre
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

Inclusion 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. Inclusion criteria are the following
i) Patients with severe and moderate acute TBI defined as
GCS of 8 or
GCS of 9-12 (moderate) with any intracranial hemorrhage seen on CT scan (patients with only subarachnoid hemorrhage are excluded)
ii) Upon randomization patient can receive the first dose of study drug in the
first 3 calendar days of the time of injury
ii) 18 years of age

Exclusion Criteria

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 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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