The Relevent trial: Rate of Lower Limb Deep Venous Thrombosis in patients with Traumatic Brain Injury (TBI): a pilot observational study

Not Applicable

• Conditions: ower limb deep venous thrombosis; Lower limb deep venous thrombosis; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12608000330347
• Lead Sponsor: Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

(1) Patients with TBI who are admitted to ICU (Glasgow Coma Scale <15), (2) age > 18 years, (3) no longer than 48 hours since primary traumatic injury, (4) expected to remain at least 96 hours in ICU.

Exclusion Criteria

(1) Pregnancy or lactation, (2) inability to perform lower limb ultrasounds, (3) lack of consent, (4) enrolment in another trial.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of lower limb deep venous thrombosis in traumatic brain injury patients admitted to intensive care during their stay in intensive care. This will be measured by means of a twice weekly venous ultrasound of both lower limbs.[The outcome will be measured within 72 hours of admission to intensive care and twice weekly thereafter until discharge from intensive care or death in intensive care.]

Secondary Outcome Measures

Name	Time	Method
The development of a hypercoaguable state will be measured by means of a specialised blood test called a thromboelastogram.[The outcome will be measured within 72 hours of admission to intensive care and twice weekly thereafter until discharge from intensive care or death in intensive care.]