Comparative Efficacy of Rivaroxaban and Enoxaparin in Post-Laparotomy DVT Prevention

November 19, 2025 updated by: Muhammad Mashhood Ahmad Shad, Mayo Hospital Lahore

Comparison Between the Efficacy of Rivaroxaban vs Enoxaparin in Post-Operative Deep Venous Thrombosis Prophylaxis After Exploratory Laparotomy

The goal of this clinical trial is to learn if rivaroxaban works better than enoxaparin to prevent deep vein thrombosis (DVT) after emergency exploratory laparotomy in adults. It will also learn about the safety of rivaroxaban compared to enoxaparin.

The main questions it aims to answer are:

Does rivaroxaban lower the number of patients who develop DVT after exploratory laparotomy compared to enoxaparin?

What medical problems or side effects do participants have when taking rivaroxaban versus enoxaparin?

Researchers will compare rivaroxaban (an oral anticoagulant) to enoxaparin (a subcutaneous injection) to see which drug works better to prevent blood clots after surgery.

Participants will:

Take rivaroxaban 10 mg orally once daily for 7 days, or enoxaparin 40 mg subcutaneously once daily for 7 days after surgery

Undergo duplex color Doppler ultrasound scans of the legs on day 5 and day 10 after surgery

Be monitored for bleeding, complications, and other side effects

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is a major and preventable cause of morbidity and mortality after surgery. Patients undergoing emergency exploratory laparotomy are at especially high risk due to prolonged operative times, systemic inflammation, and immobility. While low-molecular-weight heparins (LMWH), such as enoxaparin, are the current standard for prophylaxis, direct oral anticoagulants such as rivaroxaban offer potential advantages in terms of ease of administration, compliance, and patient comfort.

This randomized controlled trial was designed to compare the efficacy and safety of once-daily oral rivaroxaban (10 mg) with once-daily subcutaneous enoxaparin (40 mg) in preventing postoperative DVT in adult patients undergoing emergency exploratory laparotomy at Mayo Hospital, Lahore.

Eligible patients were adults aged 18-80 years undergoing emergency laparotomy for traumatic or non-traumatic indications and expected to remain immobile for more than 24 hours postoperatively. Patients with pre-existing DVT, morbid obesity (BMI ≥40), active bleeding risk, mechanical ventilation, myocardial infarction, cerebrovascular accident, or current anticoagulation therapy were excluded.

Participants were randomized using a computer-generated sequence with allocation concealment. Rivaroxaban or enoxaparin was given for 7 days postoperatively, in addition to standard perioperative care and mechanical prophylaxis.

The primary outcome was the incidence of DVT as confirmed by duplex color Doppler ultrasound on postoperative days 5 and 10. Any noncompressible or indistinct venous segment was scored as positive for DVT. Wells scores were also recorded to stratify risk.

The secondary outcomes included bleeding complications, duration of hospital stay, time to ambulation, and cost comparison between the two regimens. Safety assessments focused on clinically significant bleeding events and other adverse reactions.

A total of 212 patients were enrolled (106 in each arm). On day 5, rivaroxaban showed a significantly lower rate of DVT compared to enoxaparin (3.8% vs 12.3%). By day 10, the difference remained significant (8.5% vs 20.8%). Wells scores showed no significant differences between groups. No major bleeding events were reported in either arm.

The findings suggest that rivaroxaban is more effective than enoxaparin in reducing postoperative DVT after emergency exploratory laparotomy without increasing bleeding risk. These results add evidence that rivaroxaban may be a safe and convenient alternative to LMWH for high-risk general surgical patients. However, larger multicenter trials with longer follow-up are needed to confirm safety and evaluate long-term outcomes such as pulmonary embolism and late-onset DVT.

Study Type

Interventional

Enrollment (Estimated)

212

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54570
        • Recruiting
        • Mayo Hospital Lahore
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muhammad Mashhood Ahmad Shad, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rivaroxaban Group
Arm 1 Title: Rivaroxaban Group Arm Type: Experimental Intervention Name: Drug: Rivaroxaban Descri
Drug: rivaroxaban (10mg)

Name: Drug: Rivaroxaban

Type: Drug

Description: Participants receive rivaroxaban 10 mg orally once daily for 7 days following emergency exploratory laparotomy. All patients also receive standard perioperative management and mechanical prophylaxis as per institutional guidelines.

Other Names:
  • Xarelto
Active Comparator: Enoxaparin Group

Arm 2 Title: Enoxaparin Group

Arm Type: Active Comparator

Intervention Name: Drug: Enoxaparin

Description: Participants receive enoxaparin 40 mg subcutaneously once daily for 7 days after emergency exploratory laparotomy, in addition to standard perioperative care and mechanical prophylaxis.
Drug: Enoxaparin 40 mg SC

Name: Drug: Enoxaparin

Type: Drug

Description: Participants receive enoxaparin 40 mg subcutaneously once daily for 7 days following emergency exploratory laparotomy. All patients also receive standard perioperative management and mechanical prophylaxis as per institutional guidelines.

Other Names:
  • clexane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Deep Vein Thrombosis (DVT)
Time Frame: Postoperative Day 5 and Day 10
Presence of DVT in the lower limbs will be assessed by duplex color Doppler ultrasonography on postoperative day 5 and day 10. A noncompressible or indistinct venous segment on ultrasound will be considered positive for DVT. The outcome will be reported as the proportion of participants in each treatment arm who develop DVT.
Postoperative Day 5 and Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Hospital Lahore

Collaborators

King Edward Medical University

Investigators

  • Study Chair: Ahmad Uzair Qureshi, FCPS, Mayo Hospital Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2025

Primary Completion (Estimated)

November 10, 2025

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRSHAD-GS-2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) collected during the trial (including demographics, clinical variables, Wells scores, ultrasound results, and outcomes) will not be made publicly available. Only aggregated results will be reported in publications and presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deep Venous Thromboses

Clinical Trials on rivaroxaban (10mg)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe