Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery. (PLACARD)
연구 개요
상태
상세 설명
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:
- Characterize the impact of CPB on the formation of procoagulant platelets.
- Assess changes in platelet lipid composition and bioenergetics before, during and after cardiac surgery.
- 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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Christophe Beauloye, MD, PhD
- 전화번호: 003227642812
- 이메일: christophe.beauloye@uclouvain.be
연구 연락처 백업
- 이름: Richard Coulie, MD
- 이메일: richard.coulie@uclouvain.be
연구 장소
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Brussels, 벨기에, 1200
- Cliniques Universitaires Saint-luc
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연락하다:
- Christophe Beauloye, MD, PhD
- 전화번호: 003227642812
- 이메일: christophe.beauloye@uclouvain.be
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연락하다:
- Richard Coulie, MD
- 이메일: richard.coulie@uclouvain.be
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부수사관:
- Richard Coulie, MD
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부수사관:
- Mona Momeni, MD, PhD
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수석 연구원:
- Christophe Beauloye, MD, PhD
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Cathlab patients
This group includes patients with coronary disease and/or valvular disease scheduled for elective coronary angiography.
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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.
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
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실험적: Cardiac surgery patients
This arm includes patients with coronary disease and/or valvular disease scheduled for elective cardiac surgery with cardiopulmonary bypass.
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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.
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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Procoagulant platelet formation
기간: Throughout the entire study, approximately during 32 months
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Ex-vivo flow cytometric assessment of the pourcentage of procoagulant platelet population under basal and stimulated conditions.
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Throughout the entire study, approximately during 32 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Platelet lipidomics
기간: Throughout the entire study, approximately during 32 months
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Assessment of the impact of cardiac surgery and cardiopulmonary bypass on platelet lipid metabolism.
Pourcentage of patients with platelet Acety-CoA Carboxylase phosphorylation.
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Throughout the entire study, approximately during 32 months
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Postoperative bleeding
기간: Throughout the entire study, approximately during 32 months
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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)).
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Throughout the entire study, approximately during 32 months
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Postoperative inflammation
기간: Throughout the entire study, approximately during 32 months
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Correlation between the ex-vivo primary outcomes and biological postoperative parameters (C-reactive protein).
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Throughout the entire study, approximately during 32 months
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Postoperative platelet function
기간: Throughout the entire study, approximately during 32 months
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Correlation between the ex-vivo primary outcomes and biological postoperative parameters (platelet aggregometry results).
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Throughout the entire study, approximately during 32 months
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Postoperative coagulation
기간: Throughout the entire study, approximately during 32 months
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Correlation between the ex-vivo primary outcomes and biological postoperative parameters (thromboelastography and standard coagulation results (INR, aPTT, Fibrinogen)).
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Throughout the entire study, approximately during 32 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PLACARD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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