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Comparison of DOACs and LMWH for Thromboprophylaxis After Total Knee Arthroplasty

Sponsor: Military Hospital of Tunis • ClinicalTrials.gov ID: NCT07869615

Registry updated: 2026-10-16

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Description

Yes. For these two fields, I would enter the following in English, based on your study protocol. 1\. Brief Summary Copy and paste: This study aims to compare three thromboprophylaxis regimens in adults undergoing primary total knee arthroplasty: rivaroxaban 10 mg once daily, apixaban 2.5 mg twice daily, and low-molecular-weight heparin (LMWH) once daily. The study will assess venous blood flow in the lower limbs using Doppler ultrasound and determine whether blood flow differs between the three treatment groups. Participants will be randomly assigned to one of the three treatment groups and followed for 28 days after surgery. Doppler ultrasound examinations will be performed at baseline and on Days 7, 15, 21, and 28. Additional assessments will include rehabilitation progress, postoperative bleeding, suspected venous thromboembolism, cardiovascular complications, and other postoperative complications. The study is being conducted at the Department of Anesthesiology, Principal Military Hospital of Instruction of Tunis.

Interventions

Apixaban (Drug)
Apixaban 2.5 mg twice daily, starting 24 hours after surgery, for 14 days. Participants receive initial LMWH prophylaxis 6 hours after surgery before starting the assigned regimen.
Rivaroxaban (Drug)
Rivaroxaban 10 mg once daily, starting 24 hours after surgery, for 14 days. Participants receive initial LMWH prophylaxis 6 hours after surgery before starting the assigned regimen.
Enoxaparin (LMWH) (Drug)
Enoxaparin 40-60 mg once daily, weight-adjusted, starting 6 hours after surgery, for 14 days.

Eligibility criteria

Inclusion Criteria: * Adults aged 18 years or older undergoing elective primary unilateral total knee arthroplasty. * Able to provide informed consent. Exclusion Criteria: * Allergy or contraindication to the study medications. * Requirement for long-term therapeutic anticoagulation. * Requirement for antiplatelet therapy. * Pregnancy or lactation. * Active cancer or cancer treatment. * Documented previous venous thromboembolism in the target limb. * Hypercoagulable state. * BMI \>40 kg/m². * Severe inflammatory disease. * Age \>80 years. * Inability to comply with follow-up. * Incomplete data.

Conditions

Total Knee Arthroplasty Venous Thromboembolism

Locations

Principal Military Hospital of Instruction of Tunis — Tunis, Tunis Governorate, Tunisia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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