Efficacy of Aspirin in Preventing Venous Thromboembolism

Phase 4

Completed

• Conditions: Venous Thromboembolism (VTE); Total Joint Arthroplasty; Total Hip Arthroplasty (THA)
• Interventions: Drug: Aspirin; Drug: enoxaparin

• Registration Number: NCT06635317
• Lead Sponsor: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2022-04-24
• Primary Completion: 2022-10-24
• Study Completion: 2023-02-28
• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Long term aspirin group	Aspirin	Long term aspirin group received enoxaparin, 40 mg/day subcutaneously for 3 days, and aspirin, 100 mg/day orally for 25 days
Enoxaparin group	enoxaparin	enoxaparin group received enoxaparin, 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 Outcome Measures

Name	Time	Method
Symptomatic VTE	90 days

Secondary Outcome Measures

Name	Time	Method
Wound bleeding	90 days

Trial Locations

Locations (1)

ISSSTEP; 🇲🇽 Puebla, Mexico