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Comparison of DOACs and LMWH for Thromboprophylaxis After Total Knee Arthroplasty

ConditionVenous Thromboembolism Prevention After Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMilitary Hospital of Tunis

About this trial

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1\. Brief Summary

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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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older undergoing elective primary unilateral total knee arthroplasty.

Able to provide informed consent.

Disqualifiers

Allergy or contraindication to the study medications.

Requirement for long-term therapeutic anticoagulation.

Requirement for antiplatelet therapy.

Pregnancy or lactation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

138 Participants
are divided into 3 treatment groups
Group A: ApixabanExperimental treatment 1 intervention
Group B: RivaroxabanExperimental treatment 1 intervention
Group C: LMWHActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak Systolic Velocity (PSV) of Major Lower-Limb Veins

Peak systolic velocity (PSV) of major lower-limb veins measured by duplex Doppler ultrasound and compared between participants receiving apixaban twice daily, rivaroxaban once daily, or LMWH.

Time frame
Within 28 days after total knee arthroplasty

Secondary outcomes

1

Time-Averaged Mean Velocity (TAMEAN)

TAMEAN of major lower-limb veins measured by Doppler ultrasound.

Time frame
Within 28 days after surgery
2

Venous Flow Volume

Venous flow volume measured by Doppler ultrasound.

Time frame
Within 28 days after surgery
3

Respiratory Phasicity

Assessment of respiratory phasicity of the common femoral and popliteal veins.

Time frame
Within 28 days after surgery
4

Distal Augmentation

Assessment of distal venous flow augmentation by Doppler ultrasound.

Time frame
Within 28 days after surgery

Other outcomes

Sponsors and contacts

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Military Hospital of Tunis

Lead sponsor

Source ClinicalTrials.gov
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