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Completed

NCT Number: NCT06635317

Efficacy of Aspirin in Preventing Venous Thromboembolism

Efficacy of aspirin and enoxaparin in preventing venous tromboembolism was compared after total knee or hip arthroplasty.

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Key information

Conditions

Venous Thromboembolism (VTE) Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Total Hip Arthroplasty (THA) Total Joint Arthroplasty Vascular Diseases Venous Thromboembolism

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ISSSTEP

Puebla City, 72450, Mexico

About this study

Background: Venous thromboembolism (VTE) remains a significant risk following joint replacements, despite advancements in prevention strategies. Aspirin-based therapies have gained popularity due to their perceived safety, ease of administration, and supportive evidence.This study aimed to compare the efficacy of aspirin and enoxaparin in preventing VTE after total knee or hip arthroplasty.

Methods: Sixty patients undergoing primary total knee or hip arthroplasty were randomized to receive either aspirin or enoxaparin. The primary outcome was symptomatic VTE within 90 days. Patients were followed up for Doppler ultrasound evaluations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients provided written informed consent.
  • All patients who underwent primary total hip or total knee arthroplasty for osteoarthritis

Exclusion criteria

  • preoperative anticoagulation (direct oral anticoagulant, warfarin, IMPROVE Bleeding Score more or equal to 7, dual antiplatelet therapy)
  • medical contraindications (allergy, cancer, cardiac disease, kidney disease, or bleeding disorder precluding anticoagulation).

Treatment and study plan

Aspirin

Drug

100 mg/day orally for 25 days

Enoxaparin

Drug

40 mg/day subcutaneously for 28 days, with the dose reduced to 20 mg for patients weighing less than 50 kg or with an estimated glomerular filtration rate less than 30 mL/min/1.73 m².

Primary outcomes

  1. Symptomatic VTE

    Time frame: 90 days

Secondary outcomes

  1. Wound bleeding

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Other Gov

Registry information

Official study title

Efficacy of Arpirin in Preventing Venous Thromboembolism in Total Knee and Hip Replacement

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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