A Phase 3 interventional study of Dalteparin and Saline in Traumatic Brain Injury, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 12 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Sunnybrook Health Sciences Centre · Phase 3, Interventional, and Prevention
This is a phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 TBI defined as GCS of ≤8, or
ii) Patients with moderate TBI defined as GCS = 9-12, admitted to ICU, with at least some ICB present on initial CT scan and any of the following:
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 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
Dalteparin sodium (at a dose of 5000 IU once daily by subcutaneous injection) for 7 days upon randomization after hospital admission.
Drug: Dalteparin
Saline (0.2 mL) once daily by subcutaneous injection for 7 days upon randomization after hospital admission.
Drug: Saline
Dalteparin in prophylactic doses administered daily if screening criteria are satisfied.
Also known as: Fragmin
Saline in prophylactic doses administered daily if screening criteria are satisfied.
Also known as: Sodium Chloride
Clinically important VTE
Composite outcome of clinically-important VTE within 7±1 days after randomization defined as any of: 1. Symptomatic, objectively-confirmed pulmonary embolism (PE), or 2. Symptomatic, objectively-confirmed, proximal leg deep vein thrombosis (DVT), or 3. Proximal (above knee) leg DVT on compression ultrasonography on Day 7±1
Time frame: 8 days
Clinically-important ICB (Intracranial bleeding) progression
Clinically-important ICB progression within 7±1 days after randomization , as defined by having (1) any increase in volume of blood in the brain on any CT scan within 7±1 days relative to initial CT scan on Day 0\* AND (2) clinical worsening within 24 hours of this CT scan, defined by one or more of the following: * Surgical intervention related to increased ICB after Day 0 (craniotomy/craniectomy, ICP monitor, external ventricular drain) * Decrease of GCS (Glasgow Coma Scale) by at least 2 points not related to sedation * Increase in ICP \>5 mmHg on 2 occasions at least 6 hours apart despite medical therapy (if ICP monitor is in place) * Death
Time frame: 7 days
Objectively confirmed new or progressing ICB on radiology,
Assessed by comparing the initial brain CT (Day 0) to that performed within 8±1 days following randomization (or most recent prior to death).
Time frame: 8 days
180-day Mortality
Mortality at 180 days
Time frame: 180 days
7-day Mortality
Mortality at 7 days
Time frame: 7 days
30-day Mortality
Mortality at 30 days
Time frame: 30 days
Delayed VTE after day 7
Any clinically important VTE occurring between Day 8 to Day 30 detected by treating clinicians
Time frame: 30 days
Functional neurological outcome at day 30 as measured by Glasgow Outcome Scale Extended
Glasgow Outcome Scale Extended (GOSE) at Day 30±5 by phone interview.
Time frame: 30 days
Functional neurological outcome at day 180 as measured by Glasgow Outcome Scale Extended
Glasgow Outcome Scale Extended (GOSE) at Day 180±14 by phone interview.
Time frame: 180 days
Quality of life outcome at 30 days as measured by the EuroQol5D
EQ-5D (EuroQol 5D) at Day 30±5 by phone interview.
Time frame: 30 days
Quality of life outcome at 180 days as measured by the EuroQol5D
EQ-5D (EuroQol 5D) at Day 180±14 by phone interview.
Time frame: 180 days
Plan to share: No
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Sunnybrook Health Sciences Centre