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Efficacy of Aspirin in Preventing Venous Thromboembolism

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06635317
Enrollment
60
Registered
2024-10-10
Start date
2022-04-24
Completion date
2023-02-28
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Arthroplasty (THA), Total Joint Arthroplasty, Venous Thromboembolism (VTE)

Keywords

Aspirin, Venous thromboembolism, Total knee replacement, Total hip replacement, Thromboprophylaxis

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.

Interventions

DRUGAspirin

100 mg/day orally for 25 days

DRUGenoxaparin

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.

Sponsors

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

All patients who underwent a preoperative Doppler ultrasound of the lower extremities to screen for VTE and received antibiotic prophylaxis with cephalothin 1 gram intravenously. At six hours post-surgery, patients in the aspirin group received enoxaparin, 40 mg/day subcutaneously for 3 days, and aspirin, 100 mg/day orally for 25 days. Patients in the 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. Additionally, all patients received pneumatic compression stockings postoperatively for at least 21 days as standard care. Physical therapy was initiated on the day of surgery or postoperative day 1 and continued daily throughout the hospital stay. Postoperative wound care and Doppler ultrasound evaluations were performed at two and four weeks postoperatively to detect any evidence of VTE.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Symptomatic VTE90 days

Secondary

MeasureTime frame
Wound bleeding90 days

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026