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

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: Not yet recruiting
• Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Platelet Activation
• Intervention / Treatment: Biological: Arterial blood sample; Biological: Arterial blood sample

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: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe Beauloye, MD, PhD; Phone Number: 003227642812; Email: christophe.beauloye@uclouvain.be
• Study Contact Backup: Name: Richard Coulie, MD; Email: richard.coulie@uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc
    • Contact: Christophe Beauloye, MD, PhD; Phone Number: 003227642812; Email: christophe.beauloye@uclouvain.be
    • Contact: Richard Coulie, MD; Email: richard.coulie@uclouvain.be
    • Sub-Investigator: Richard Coulie, MD
    • Sub-Investigator: Mona Momeni, MD, PhD
    • Principal Investigator: Christophe Beauloye, MD, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Procoagulant platelet formation	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

Outcome Measure	Measure Description	Time Frame
Platelet lipidomics	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	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	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	Correlation between the ex-vivo primary outcomes and biological postoperative parameters (platelet aggregometry results).	Throughout the entire study, approximately during 32 months
Postoperative coagulation	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

• Sponsor: Université Catholique de Louvain
• Collaborators: Fonds National de la Recherche Scientifique; Fondation Mont-Godinne

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative bleeding; Procoagulant platelets; Platelet lipidomics; Postoperative inflammation
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Hemorrhage; Pathological Conditions, Signs and Symptoms; Postoperative Hemorrhage
• Other Study ID 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