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

NCT07630987 | Not Yet Recruiting

• 1 other identifier: PLACARD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Surgery; Cardiopulmonary Bypass; Platelet Activation

Keywords

Procoagulant platelets; Platelet lipidomics; Postoperative inflammation; Postoperative bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Platelet lipidomics

  Throughout the entire study, approximately during 32 months

• Postoperative bleeding

  Throughout the entire study, approximately during 32 months

• Postoperative inflammation

  Throughout the entire study, approximately during 32 months

• Postoperative platelet function

  Throughout the entire study, approximately during 32 months

• Postoperative coagulation

  Throughout the entire study, approximately during 32 months

Study Arms (2)

Cathlab patients

EXPERIMENTAL

This group includes patients with coronary disease and/or valvular disease scheduled for elective coronary angiography.

Biological: Arterial blood sample

Cardiac surgery patients

EXPERIMENTAL

This arm includes patients with coronary disease and/or valvular disease scheduled for elective cardiac surgery with cardiopulmonary bypass.

Biological: Arterial blood sample

Interventions

Arterial blood sample BIOLOGICAL

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.

Cathlab patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• Fondation Mont-Godinne: collaborator
• Fonds National de la Recherche Scientifique: collaborator

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Central Study Contacts

Christophe Beauloye, MD, PhD

CONTACT

003227642812; christophe.beauloye@uclouvain.be

Richard Coulie, MD

CONTACT

richard.coulie@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 5, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)