Efficacy of Aspirin in Preventing Venous Thromboembolism

October 8, 2024 updated by: Ana Luisa Galicia Zamalloa, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Puebla, Mexico, 72450
        • ISSSTEP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Long term aspirin group
Long term aspirin group received enoxaparin, 40 mg/day subcutaneously for 3 days, and aspirin, 100 mg/day orally for 25 days
Drug: Aspirin
100 mg/day orally for 25 days
Active Comparator: Enoxaparin group
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptomatic VTE
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Wound bleeding
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2022

Primary Completion (Actual)

October 24, 2022

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151.2022 (Other Identifier: ISSSTE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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