Comparative Efficacy of Rivaroxaban and Enoxaparin in Post-Laparotomy DVT Prevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rivaroxaban (10mg), Enoxaparin 40 mg SC.
- Who it may be relevant to
- Registry conditions: Deep Venous Thromboses, Laparotomy Patients. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison Between the Efficacy of Rivaroxaban vs Enoxaparin in Post-Operative Deep Venous Thrombosis Prophylaxis After Exploratory Laparotomy
Overview
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
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.
Interventions
- 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. - 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.
Primary outcome measures
- Incidence of Deep Vein Thrombosis (DVT) [Time frame: Postoperative Day 5 and Day 10]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Pakistan · 1 center
- Mayo Hospital Lahore — Lahore
Identifiers
NCT: NCT07243080 · DRSHAD-GS-2025-001