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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité Catholique de Louvain

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Uninterrupted preoperative dual antiplatelet therapy

Active chronic inflammatory disease

Recent chemotherapy or immunotherapy (< 3 months)

Active solid malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Arterial blood sample

    Biological/Vaccine

    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.

  • Arterial blood sample

    Biological/Vaccine

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Cathlab patientsExperimental treatment 1 intervention
Group B: Cardiac surgery patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Procoagulant platelet formation

Ex-vivo flow cytometric assessment of the pourcentage of procoagulant platelet population under basal and stimulated conditions.

Time frame
Throughout the entire study, approximately during 32 months

Secondary outcomes

1

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.

Time frame
Throughout the entire study, approximately during 32 months
2

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)).

Time frame
Throughout the entire study, approximately during 32 months
3

Postoperative inflammation

Correlation between the ex-vivo primary outcomes and biological postoperative parameters (C-reactive protein).

Time frame
Throughout the entire study, approximately during 32 months
4

Postoperative platelet function

Correlation between the ex-vivo primary outcomes and biological postoperative parameters (platelet aggregometry results).

Time frame
Throughout the entire study, approximately during 32 months

Other outcomes

Sponsors and contacts

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Université Catholique de Louvain

Lead sponsor

Fonds National de la Recherche Scientifique

Collaborator

Fondation Mont-Godinne

Collaborator

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