Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery. (PLACARD)

June 2, 2026 updated by: Université Catholique de Louvain
The PLACARD research project aims to investigate the impact of CPB-induced platelet modifications during cardiac surgery on the post-operative inflammatory response and bleeding complications. Our objectives are to study the impact of CPB on the formation of procoagulant platelets, to assess changes in platelet lipid profile and bioenergetics before, during and after cardiac surgery, and to connect the ex-vivo observations to post-operative clinical and biological parameters of these patients during their stay in cardiovascular intensive care unit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cardiac surgery remains associated with high morbidity and mortality despite improvements in peri and post-operative care. Cardiopulmonary bypass (CPB) triggers a sterile inflammatory response, characterized by vascular hyperpermeability, excessive vasodilation, and cardiac arrythmias, i.e. atrial fibrillation. In parallel, major peri-operative bleeding frequently necessitates transfusion of allogeneic blood products. The pathophysiology underlying these complications is multifactorial. Direct contact of blood with the CPB tubing system, combined with ischemia-reperfusion injury, profoundly alters both the inflammatory and haemostatic systems. Among blood components, platelets are particularly vulnerable to CPB-induced alterations. Platelet dysfunction is widely recognized as the main haemostatic defect associated with CPB and a major contributor to post-operative bleeding. Recent findings have demonstrated that platelet lipid metabolism plays a key role in regulating thrombo-inflammatory responses in sepsis. These observations raise the hypothesis that CPB-induced alterations in platelet lipid metabolism may critically modulate the balance between inflammation and haemostasis in cardiac surgery.

The PLACARD project therefore aims to investigate how CPB-induced platelet modifications influence post-operative inflammatory responses and bleeding complications.

Specific objectives:

  1. Characterize the impact of CPB on the formation of procoagulant platelets.
  2. Assess changes in platelet lipid composition and bioenergetics before, during and after cardiac surgery.
  3. Correlate ex-vivo platelet alterations with post-operative clinical outcomes and biological markers during the stay in the cardiovascular intensive care unit.

This project addresses a critical unmet need in cardiac surgery: understanding the mechanistic link between CPB-induced platelet dysfunction and thrombo-inflammatory complications. By focusing on platelet lipid metabolism, a pathway largely unexplored in this context, the project moves beyond traditional platelet function assays. The results are expected to provide fundamental mechanistic insights into procoagulant platelet formation during CPB and may identify novel biomarkers or therapeutic targets to reduce bleeding and inflammatory complications in high-risk surgical patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Richard Coulie, MD
        • Sub-Investigator:
          • Mona Momeni, MD, PhD
        • Principal Investigator:
          • Christophe Beauloye, MD, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (≥ 18 years old) suffering from coronary disease and/or severe valvular dysfunction (mitral or aortic) undergoing elective coronary angiography or cardiac surgery with cardiopulmonary bypass.

Exclusion Criteria:

  • Uninterrupted preoperative dual antiplatelet therapy
  • Active chronic inflammatory disease
  • Recent chemotherapy or immunotherapy (< 3 months)
  • Active solid malignancy
  • History of hematologic malignancy
  • Hemophilia or other coagulopathy
  • History of thrombocytopenia (< 100,000 platelets/mm³)
  • Recent administration of thrombopoietin receptor agonist or immunoglobulins
  • History of thrombopathy, thrombocytosis, or myeloproliferative syndrome
  • History of heparin-induced thrombocytopenia (HIT)
  • Cirrhosis or hepatic fibrosis (with or without hypersplenism)
  • History of splenectomy, regardless of initial indication
  • History of systemic autoimmune disease (e.g., systemic lupus erythematosus, scleroderma, antiphospholipid syndrome, systemic vasculitis)
  • Recent major surgery (< 3 months)
  • Severe renal insufficiency (eGFR ≤ 30 mL/min/m²) with or without dialysis
  • Recent or chronic corticosteroid therapy
  • Recent acute coronary syndrome, STEMI type (< 3 months)
  • Urgent surgery or procedure
  • Preoperative hemodynamic instability

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cathlab patients
This group includes patients with coronary disease and/or valvular disease scheduled for elective coronary angiography.
Biological: Arterial blood sample
An arterial blood sample will be obtained at the beginning of the coronary angiography by using the arterial sheat in place, before administration of Heparin.
Biological: Arterial blood sample
An arterial blood sample will be obtained via the arterial line before anesthetic induction, 60 minutes after the beginning of cardiopulmonary bypass and 4 hours after the arrival in the intensive care unit
Experimental: Cardiac surgery patients
This arm includes patients with coronary disease and/or valvular disease scheduled for elective cardiac surgery with cardiopulmonary bypass.
Biological: Arterial blood sample
An arterial blood sample will be obtained at the beginning of the coronary angiography by using the arterial sheat in place, before administration of Heparin.
Biological: Arterial blood sample
An arterial blood sample will be obtained via the arterial line before anesthetic induction, 60 minutes after the beginning of cardiopulmonary bypass and 4 hours after the arrival in the intensive care unit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Procoagulant platelet formation
Time Frame: Throughout the entire study, approximately during 32 months
Ex-vivo flow cytometric assessment of the pourcentage of procoagulant platelet population under basal and stimulated conditions.
Throughout the entire study, approximately during 32 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Platelet lipidomics
Time Frame: Throughout the entire study, approximately during 32 months
Assessment of the impact of cardiac surgery and cardiopulmonary bypass on platelet lipid metabolism. Pourcentage of patients with platelet Acety-CoA Carboxylase phosphorylation.
Throughout the entire study, approximately during 32 months
Postoperative bleeding
Time Frame: Throughout the entire study, approximately during 32 months
Correlation between the ex-vivo primary outcomes and clinical postoperative parameters (chest drain output (mL) and need for blood transfusion (units of packed red cells, fresh frozen plasma, platelets and fibrinogen)).
Throughout the entire study, approximately during 32 months
Postoperative inflammation
Time Frame: Throughout the entire study, approximately during 32 months
Correlation between the ex-vivo primary outcomes and biological postoperative parameters (C-reactive protein).
Throughout the entire study, approximately during 32 months
Postoperative platelet function
Time Frame: Throughout the entire study, approximately during 32 months
Correlation between the ex-vivo primary outcomes and biological postoperative parameters (platelet aggregometry results).
Throughout the entire study, approximately during 32 months
Postoperative coagulation
Time Frame: Throughout the entire study, approximately during 32 months
Correlation between the ex-vivo primary outcomes and biological postoperative parameters (thromboelastography and standard coagulation results (INR, aPTT, Fibrinogen)).
Throughout the entire study, approximately during 32 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Catholique de Louvain

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fonds National de la Recherche Scientifique
Fondation Mont-Godinne

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PLACARD

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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