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

ConditionsDeep Venous Thromboses Laparotomy Patients

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-80

SponsorMayo Hospital Lahore

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

212 Participants

are divided into 2 treatment groups

Group A: Rivaroxaban GroupActive comparator 1 intervention

Group B: Enoxaparin GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Postoperative Day 5 and Day 10

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Hospital Lahore

Lead sponsor

King Edward Medical University

Collaborator

Source ClinicalTrials.gov

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