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Recruiting
NCT07630987
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Conditions: Cardiac Surgery, Cardiopulmonary Bypass, Platelet Activation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Université Catholique de Louvain
Location: Cliniques universitaires Saint-Luc Brussels
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07630987). StuddyBuddy aggregates publicly available trial information.