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

NCT07243080 | Recruiting Phase 4

• 1 other identifier: DRSHAD-GS-2025-001
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Deep Venous Thromboses; Laparotomy Patients

Keywords

Deep Vein Thrombosis; Exploratory Laparotomy; Rivaroxaban; Enoxaparin; Venous Thromboembolism; Anticoagulation; Prophylaxis; Randomized Controlled Trial; Thromboprophylaxis

Outcome Measures

Primary Outcomes (1)

• Incidence of Deep Vein Thrombosis (DVT)

  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

Study Arms (2)

Rivaroxaban Group

ACTIVE COMPARATOR

Arm 1 Title: Rivaroxaban Group Arm Type: Experimental Intervention Name: Drug: Rivaroxaban Descri

Drug: rivaroxaban (10mg)

Enoxaparin Group

ACTIVE COMPARATOR

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

Interventions

rivaroxaban (10mg) DRUG

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.

Also known as: Xarelto

Rivaroxaban Group

Enoxaparin 40 mg SC DRUG

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.

Also known as: clexane

Enoxaparin Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Hospital Lahore: lead
• King Edward Medical University: collaborator

Study Sites (1)

Mayo Hospital Lahore

Lahore, Punjab Province, 54570, Pakistan

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis; Venous Thromboembolism

Interventions

Rivaroxaban; Enoxaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Ahmad Uzair Qureshi, FCPS

  Mayo Hospital Lahore

  STUDY CHAIR

Central Study Contacts

Muhammad Mashhood Shad, FCPS

CONTACT

+923040420285; mashhood_shad@yahoo.com

Shahroze Wajid, FCPS

CONTACT

+923054480616; mashhood0285@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This randomized, parallel-group, Phase 4 clinical trial enrolled a total of 212 adult patients undergoing emergency exploratory laparotomy at Mayo Hospital, Lahore. Participants were allocated in a 1:1 ratio to one of two arms: Arm 1: Rivaroxaban 10 mg orally once daily for 7 days Arm 2: Enoxaparin 40 mg subcutaneously once daily for 7 days Allocation was performed using a computer-generated randomization sequence with concealment via sealed opaque envelopes. The trial used single masking (outcomes assessor blinded); the radiologist performing duplex ultrasonography and the data analyst were blinded to group allocation. The study compared the two interventions in parallel to evaluate the incidence of postoperative deep vein thrombosis (DVT) on days 5 and 10, as detected by duplex color Doppler ultrasound.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: October 10, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)