CTRI/2022/12/048107Not yet recruitingPhase 2/3
Randomised Control Trial to Compare efficacy of Dabigatran versus Aspirin in Prevention of Venous Thromboembolism in Pelvic and Acetabular injuries
Chinmoy Sharma1 site in 1 country90 target enrollmentStarted: December 20, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Primary/Main outcome - The incidence of Deep vein thrombosis in patients treated with eithe Dabigatran or Aspirin
Study Overview
Brief Summary
AIM OF STUDY
To assess and compare the efficacy and safety of Dabigatran and Aspirin in prevention of Venous Thromboembolism in Pelvic and Acetabular injuries
OBJECTIVES
1. To compare the effectiveness of Dabigatran and Aspirin in preventing Symptomatic or Asymptomatic Deep vein Thrombosis .
2. To compare the safety of Dabigatran and Aspirin in terms of major post-surgical haemorrhage.
Hypothesis - Dabigatran is more effective than aspirin in preventing Thromboembolism
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with Pelvic and Acetabular fractures above 18 years of age, treated surgically or conservatively and requiring 6 weeks or more of immobilization will be included in the study.
Exclusion Criteria
- •Patients below 18 years of age
- •Patients with open injuries of the lower limb requiring external fixators/soft tissue cover in the form of grafts/flaps which precludes compression stockings application will be excluded.
- •Patients with Bilateral/contralateral lower limb injuries
- •Patients with concomitant head/ abdominal injury requiring intervention
- •Patients with previous history of Venous Thromboembolism, coagulopathies, malignancy,
- •Patients with Impaired Kidney function
- •Patients with previous non ambulatory status,
- •Patients on anticoagulant therapy
- •Patients who do not consent for the study will be excluded
- •Patients lost to follow up will be excluded.
Outcomes
Primary Outcomes
Primary/Main outcome - The incidence of Deep vein thrombosis in patients treated with eithe Dabigatran or Aspirin
Time Frame: DVT will be assessed by venous doppler at 6 weeks and 12 weeks from date of surgery or date of trauma( if treated conservatively)
Secondary Outcomes
- The secondary outcome would be the incidence of major bleeding events in either of the two categories. Major bleeding events means the requirement of surgical intervention(Major bleeding event would normally follow up at our hospital. Or else it will be assessed at 6 weeks and 12 weeks follow up if managed in other hospitals)
Investigators
Study Sites (1)
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