Continuation of Aspirin Before Isolated Heart Valve Surgery | NCT05151796

Studies
Continuation of Aspirin Before Isolated Heart Valve Surgery

NCT05151796

Sponsor

University of Liege

Status

Unknown status

Last Update Posted

Dec 9, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Isolated Heart Valve Surgery

Interventions

Aspirin

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2012Actual

Primary Completion Date

May 1, 2017Actual

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Oct 5, 2021

First Submission Date that Met QC Criteria

Nov 25, 2021

First Posted Date

Dec 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2021

Last Update Posted Date

Dec 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jean François Brichant, Professor of Anesthesia, University of LiegePrincipal Investigator

Lead Sponsor

University of LiegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aspirin continued within 5 days before surgery			Drug: Aspirin
Aspirin discontinued more than 5 days before surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspirin	Drug	Daily aspirin intake for cardiovascular prevention	Aspirin continued within 5 days before surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Chest tube drainage	volume of chest tube drainage	24 hours
Surgical revision for bleeding		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gregory Hans, MD	Contact			G.Hans@chuliege.be

Overall Officials

Name	Affiliation	Role
Vincent Bonhomme, MD, PhD	Centre Hospitalier Universitaire de Liege	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU of Liege	Recruiting	Liège	Liege	4000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38146908	Derived	Houben AM, Crepy M, Senard M, Bonhomme V, Tchana-Sato V, Hans G. Preoperative continuation of aspirin before isolated heart valve surgery and postoperative bleeding and transfusion: a single-center retrospective study. Acta Chir Belg. 2024 Aug;124(4):274-280. doi: 10.1080/00015458.2023.2298097. Epub 2023 Dec 26.

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives