Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement (TBP-ASPIR)

November 23, 2021 updated by: University Hospital, Strasbourg, France

Aspirin Thromboprophylaxis After First-line Total Hip and Knee Replacement. Comparison With Baseline Low Molecular Weight Heparin Prophylaxis

Annually, more than 100,000 total hip prostheses (THA) and more than 100,000 total knee prostheses (TKA) are implanted for osteoarthritis in France, and these figures are set to increase significantly in the future as in all industrialized countries. . Venous thrombosis is a potentially serious complication after PTH and PTG, justifying various prophylactic measures. In France, aggressive prophylaxis with low molecular weight heparin (LMWH) or direct oral anticoagulants (DOA) was until recently recommended, because this drug is considered to be the most effective, at the cost of a bleeding risk implicitly assumed but often poorly. evaluated. A recent publication suggests that the risk of bleeding is currently greater than the risk of a thromboembolic event.

More recently, foreign or international recommendations have broadened the range of these recommendations, notably by introducing aspirin as a possible prophylactic agent. While this molecule is potentially less effective than LMWHs or ADOs, it could decrease the risk of iatrogenic hemorrhage. The introduction of enhanced recovery procedures after surgery (RAAC) could decrease the risk of thrombosis without modifying the risk of bleeding, and thereby improve the cost-benefit ratio of aspirin, justifying its recent inclusion in the current French recommendations when The operated follows such a protocol.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie Orthopédique Pédiatrique - Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Jean-Yves JENNY, MD, PhD
        • Sub-Investigator:
          • Alexandre DIDIER, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patient operated on for a first-line total hip or knee replacement by the principal investigator;

Description

Inclusion criteria:

  • Adult patient (≥ 18 years old);
  • Patient operated on for a first-line total hip or knee replacement by the principal investigator;
  • Patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

- Subject having expressed opposition to participating in the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Study of the postoperative thromboembolic complications after implantation of hip and knee prostheses
Time Frame: Files analysed retrospectively from July 01, 2016 to December 31, 2020 will be examined]
Files analysed retrospectively from July 01, 2016 to December 31, 2020 will be examined]

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

June 18, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8299

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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