Cardiac SurgeryPLACARDNCT07630987
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
A study testing Arterial blood sample in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass, Platelet Activation
- What is being tested?
- Arterial blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Apr 2026to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Richard Coulie, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Christophe Beauloye, MD, PhD, 003227642812, christophe.beauloye@uclouvain.be
Richard Coulie, MD, richard.coulie@uclouvain.be
About this study
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.
Read the detailed description
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.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Platelet Activation
- Being tested
- Arterial blood sample
- Keywords
- Procoagulant platelets, Platelet lipidomics, Postoperative inflammation, Postoperative bleeding
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial blood sampleBiological
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 sampleBiological
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
| Study group | Role | What they receive |
|---|---|---|
| Cathlab patients | Experimental | This group includes patients with coronary disease and/or valvular disease scheduled for elective coronary angiography. Receives: 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. Receives: Biological: Arterial blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procoagulant platelet formation
Ex-vivo flow cytometric assessment of the pourcentage of procoagulant platelet population under basal and stimulated conditions.
Measured: Throughout the entire study, approximately during 32 months
Secondary outcomes (5)
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.
Measured: Throughout the entire study, approximately during 32 months
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)).
Measured: Throughout the entire study, approximately during 32 months
Postoperative inflammation
Correlation between the ex-vivo primary outcomes and biological postoperative parameters (C-reactive protein).
Measured: Throughout the entire study, approximately during 32 months
Postoperative platelet function
Correlation between the ex-vivo primary outcomes and biological postoperative parameters (platelet aggregometry results).
Measured: Throughout the entire study, approximately during 32 months
Postoperative coagulation
Correlation between the ex-vivo primary outcomes and biological postoperative parameters (thromboelastography and standard coagulation results (INR, aPTT, Fibrinogen)).
Measured: Throughout the entire study, approximately during 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start15 Apr 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique, Fondation Mont-Godinne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630987
- Sponsor's protocol ID
- PLACARD
- Acronym
- PLACARD
- Status last verified
- Nov 2026
- First submitted
- 7 May 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT07630987
- Acronym / sponsor ID
- PLACARD / PLACARD
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Platelet Activation
- Keywords
- Procoagulant platelets, Platelet lipidomics, Postoperative inflammation, Postoperative bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique, Fondation Mont-Godinne
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cathlab patients | Experimental | Biological: Arterial blood sampleThis group includes patients with coronary disease and/or valvular disease scheduled for elective coronary angiography. |
| Cardiac surgery patients | Experimental | Biological: Arterial blood sampleThis arm includes patients with coronary disease and/or valvular disease scheduled for elective cardiac surgery with cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (19 listed)
- Uninterrupted preoperative dual antiplatelet therapy
- Active chronic inflammatory disease
- Recent chemotherapy or immunotherapy (< 3 months)
- Active solid malignancy
- History of hematologic malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial blood sampleAn arterial blood sample will be obtained at the beginning of the coronary angiography by using the arterial sheat in place, before administration of Heparin. | Biological | Cathlab patients |
| Arterial blood sampleAn 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 | Biological | Cardiac surgery patients |
Primary outcome
Procoagulant platelet formation
Time frame: 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.
5 secondary outcomes
Platelet lipidomics
Time frame: Throughout the entire study, approximately during 32 months
Postoperative bleeding
Time frame: Throughout the entire study, approximately during 32 months
Postoperative inflammation
Time frame: Throughout the entire study, approximately during 32 months
Postoperative platelet function
Time frame: Throughout the entire study, approximately during 32 months
Postoperative coagulation
Time frame: Throughout the entire study, approximately during 32 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Coulie, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial blood sample in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Beauloye, MD, PhD (003227642812, christophe.beauloye@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procoagulant platelet formation (time frame: Throughout the entire study, approximately during 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.