Rivaroxaban versus enoxaparin to prevent blood clots after exploratory laparotomy
Comparison Between the Efficacy of Rivaroxaban vs Enoxaparin in Post-Operative Deep Venous Thrombosis Prophylaxis After Exploratory Laparotomy
PHASE4 · Mayo Hospital Lahore · NCT07243080
This trial will test whether taking rivaroxaban pills once daily prevents deep vein clots better than daily enoxaparin injections in adults after emergency exploratory laparotomy.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mayo Hospital Lahore (other) |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07243080 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial at Mayo Hospital Lahore comparing once-daily oral rivaroxaban (10 mg) with once-daily subcutaneous enoxaparin (40 mg) for seven days after emergency exploratory laparotomy in adults aged 18–80. Participants are randomized with allocation concealment and receive standard perioperative care plus the assigned anticoagulant. Leg duplex Doppler ultrasounds are performed on postoperative day 5 and day 10 to detect deep vein thrombosis, and patients are monitored for bleeding and other adverse events. The trial excludes patients with preoperative DVT, morbid obesity (BMI ≥40), mechanical ventilation, recent myocardial infarction or stroke, or ongoing anticoagulation.
Who should consider this trial
Good fit: Adults aged 18 to 80 who undergo emergency exploratory laparotomy and are expected to be immobile for more than 24 hours, without pre-existing DVT or high bleeding risk, are ideal candidates.
Not a fit: Patients with active bleeding risk, BMI ≥40, those on mechanical ventilation, with recent myocardial infarction or stroke, or already taking anticoagulants are unlikely to be eligible or to benefit from this comparison.
Why it matters
Potential benefit: If successful, patients could have fewer post-operative blood clots and avoid daily injections by using a short course of an oral anticoagulant.
How similar studies have performed: Direct oral anticoagulants like rivaroxaban have shown efficacy for VTE prevention in orthopedic and some medical settings, but their use specifically after emergency exploratory laparotomy is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:• Patients aged 18 to 80 years * Both male or female patients * Patients who have undergone emergent exploratory laparotomy for any reason whether traumatic or non-traumatic * Patients with expected immobility for more than 24 hours Exclusion Criteria: * Patients with diagnosed pre-operative DVT * BMI more than 40 * Patient who are on mechanical ventilation post operatively * Patient with postoperative Myocardial infarction, ischemic heart disease or cerebrovascular accident * Patients who have undergone limb surgery in addition to exploratory laparotomy
Where this trial is running
Lahore, Punjab Province
- Mayo Hospital Lahore — Lahore, Punjab Province, Pakistan (RECRUITING)
Study contacts
- Study coordinator: Muhammad Mashhood Shad, FCPS
- Email: mashhood_shad@yahoo.com
- Phone: +923040420285
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Deep Venous Thromboses, Laparotomy Patients, Deep Vein Thrombosis, Exploratory Laparotomy, Rivaroxaban, Enoxaparin, Venous Thromboembolism, Anticoagulation