A randomized controlled trial of Prevention of severe thromboembolism in Indian patients presenting with severe brain injury

Phase 3

• Conditions: Health Condition 1: S069- Unspecified intracranial injury

• Registration Number: CTRI/2023/08/056550
• Lead Sponsor: Sunnybrook Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients with severe and moderate acute TBI defined as:

a. GCS of =8 or

b. 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 (within 72 hours after 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 heparininduced 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

If it is determined after enrolment that if an enrolled patient had an exclusion criterion at

the time of randomization which was not previously identified, the study drug will be

discontinued. In these situations, the steering committee will review each case to

determine whether the patient should also be excluded from the intention to treat

analysis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Symptomatic, objectively-confirmed PE. <br/ ><br>2. Symptomatic, objectively-confirmed, proximal leg DVT. In this case, <br/ ><br>symptomatic would suggest that the patient has developed leg swelling or <br/ ><br>signs of venous stasis that can be directly attributed to a DVT during the first <br/ ><br>7 study days, and this DVT would need to be objectively confirmed (for <br/ ><br>example using Doppler ultrasound). <br/ ><br>3. Asymptomatic proximal leg DVT on Doppler ultrasound on Day 8-1 or +2 days <br/ ><br>(at Day 7, 8, 9 or 10) after Initiation of study drug. In this case, the DVT is <br/ ><br>detected during our routine screening on Day 8-1 or +2 days (at Day 7, 8, 9 or <br/ ><br>10), and need not be associated with symptomsTimepoint: 30 days, 180 days