Is Dabigatran better than aspirin in preventing blood clots in deep veins after fractures of the pelvis and acetabulum

Randomised Control Trial to Compare efficacy of Dabigatran versus Aspirin in Prevention of Venous Thromboembolism in Pelvic and Acetabular injuries

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048107

Enrollment

Registered

2022-12-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I824- Acute embolism and thrombosis of deep veins of lower extremity Health Condition 2: S329- Fracture of unspecified parts of lumbosacral spine and pelvis

Interventions

Intervention1: Dabigatran Etexilate: Dose - 110 mg Frequency - twice daily Route- Oral Duration - 6 weeks Control Intervention1: Aspirin: Dose - 150 mg Frequency - once daily Route- Oral Duration - 6

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Patients below 18 years of age 2. 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. 3. Patients with Bilateral/contralateral lower limb injuries 4. Patients with concomitant head/ abdominal injury requiring intervention 5. Patients with previous history of Venous Thromboembolism, coagulopathies, malignancy, 6. Patients with Impaired Kidney function 7. Patients with previous non ambulatory status, 8. Patients on anticoagulant therapy 9. Patients who do not consent for the study will be excluded 10. Patients lost to follow up will be excluded.

Design outcomes

Primary

Measure	Time frame
Primary/Main outcome - The incidence of Deep vein thrombosis in patients treated with eithe Dabigatran or AspirinTimepoint: 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

Measure	Time frame
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 interventionTimepoint: 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	—

Countries

India

Contacts

Public ContactChinmoy Sharma

Ganga Medical Centre and Hospitals Pvt Ltd

agraharamdevendra@gmail.com9994399441

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026