Continuation of Aspirin Before Isolated Heart Valve Surgery

November 25, 2021 updated by: Jean François Brichant, University of Liege

Effect of Continuation of Aspirin Before Isolated Heart Valve Surgery on Postoperative Bleeding and Transfusion: a Single-center Retrospective Study

Whether or not continuing aspirin up to de day before surgery increases the risk of bleeding and/or prevents thrombo-embolic complications remains debated. The investigators retrospectively investigated the whether continuing aspirine within 5 days of isolated heart valve surgery increased the risk of bleeding.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

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

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 patients undergoing isolated heart valve surgery at the University Hospital of Liege (Belgium)

Description

Inclusion Criteria:

  • Isolated heart valve surgery

Exclusion Criteria:

  • Antiplatelet agent other than aspirin or anticoagulant not discontinued preoperatively
  • Emergent or salvage surgery
  • Surgery for endocarditis
  • Use of NSAIDs within 48 hours before surgery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Aspirin continued within 5 days before surgery
Drug: Aspirin
Daily aspirin intake for cardiovascular prevention
Aspirin discontinued more than 5 days before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of units of packed red blood cells transfused anytime during the hospital stay
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest tube drainage
Time Frame: 24 hours
volume of chest tube drainage
24 hours
Surgical revision for bleeding
Time Frame: 24 hours
24 hours
Any thrombo-embolic complication
Time Frame: 30 days
30 days
Transfusion of any type of blood product
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

University of Liege

Investigators

  • Study Chair: Vincent Bonhomme, MD, PhD, Chu of Liège

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)

May 1, 2012

Primary Completion (Actual)

May 1, 2017

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ulganescardio_aspirine

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

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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