Continuation of Aspirin Before Isolated Heart Valve Surgery

• Sponsor: University of Liege (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05151796
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 115
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Isolated Heart Valve Surgery	Drug: Aspirin

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Effect of Continuation of Aspirin Before Isolated Heart Valve Surgery on Postoperative Bleeding and Transfusion: a Single-center Retrospective Study
• Actual Study Start Date: May 1, 2012
• Actual Primary Completion Date: May 1, 2017
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. The number of units of packed red blood cells transfused anytime during the hospital stay [30 days]

Secondary Outcome Measures

1. Chest tube drainage [24 hours]

   volume of chest tube drainage

2. Surgical revision for bleeding [24 hours]

3. Any thrombo-embolic complication [30 days]

4. Transfusion of any type of blood product [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU of Liege	Liège	Liege	Belgium	4000

Sponsors and Collaborators

• University of Liege

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jean François Brichant, Professor of Anesthesia, University of Liege
• ClinicalTrials.gov Identifier: NCT05151796
• Other Study ID Numbers: ulganescardio_aspirine
• First Posted: Dec 9, 2021
• Last Update Posted: Dec 9, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aspirin

Study Results

No Results Posted as of Dec 9, 2021