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

2. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Belgia
      • Brussels, Belgia, 1200
        • Cliniques Universitaires Saint-luc
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Richard Coulie, MD
        • Underetterforsker:
          • Mona Momeni, MD, PhD
        • Hovedetterforsker:
          • Christophe Beauloye, MD, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cathlab patients
This group includes patients with coronary disease and/or valvular disease scheduled for elective coronary angiography.
Biologisk: 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.
Biologisk: 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
Eksperimentell: Cardiac surgery patients
This arm includes patients with coronary disease and/or valvular disease scheduled for elective cardiac surgery with cardiopulmonary bypass.
Biologisk: 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.
Biologisk: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Procoagulant platelet formation
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Platelet lipidomics
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Université Catholique de Louvain

Samarbeidspartnere

Fonds National de la Recherche Scientifique
Fondation Mont-Godinne

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. mai 2026

Primær fullføring (Antatt)

1. januar 2029

Studiet fullført (Antatt)

1. januar 2030

Datoer for studieregistrering

Først innsendt

7. mai 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PLACARD

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