Overview

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

Status:
Recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sunnybrook Health Sciences Centre

Collaborators:

Canadian Institutes of Health Research (CIHR)
Sunnybrook Research Institute

Treatments:

Anticoagulants
Dalteparin
Heparin, Low-Molecular-Weight
Tinzaparin

Criteria

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:

1. GCS of ≤8 or

2. 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