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The goal of this study is to determine whether the Platelet Clot Stiffness (PCS) measured by QUANTRA® is predictive of an abnormality in primary haemostasis intraoperatively in cardiac surgery performed under extracorporeal circulation.
The aim is to compare the assessment of platelet function by QUANTRA® (data called PCS, obtained in around ten minutes) with laboratory tests which are validated, but which cannot be used in current practice (response time too long, in particular). We are therefore seeking to determine whether QUANTRA is reliable in the search for a primary hemostasis anomaly, defined by significant thrombocytopenia (platelet count below 100G/L), and/or a prolongation of platelet occlusion time measured by PFA-200® (normal or increased).
This clinical research project will last 12 months. It will take place in the cardiac surgery operating room at CHU Félix Guyon, and will involve 100 patients.
Patients who have consented to participate in this research project will be managed in the operating room in the usual way, with no change to their usual care (in terms of treatments received). At the end of the surgery, we will add 3 blood samples (maximum 8.1ml) for analysis to assess platelet function and compare with QUANTRA data.
This blood sample will be the only procedure performed. Medical management remains standard and will not be disrupted by this test.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Biological | Additional 8.1 ml blood sample |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of a primary haemostasis disorder | Significant thrombocytopenia (platelet count below 100G/L), and/or prolonged platelet occlusion time measured by PFA-200® (normal or increased), depending on the PCS value obtained by QUANTRA®. | Two years |
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Inclusion Criteria:
Patients
Exclusion Criteria:
Patients:
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The patients included in this study were those hospitalized for scheduled cardiac surgery performed under extracorporeal circulation (including coronary bypass, valve replacement, aortic arch and combined surgeries), at the Centre Hospitalier Universiataire de la Réunion, Hopital Félix Guyon.
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| Name | Affiliation | Role |
|---|---|---|
| Margot CARON, Dr | University Hospital of Reunion Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Reunion Island - Cardiac reanimation department | Saint-Denis | Reunion | 97400 | Reunion |
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| ID | Term |
|---|---|
| C531844 | Von willebrand factor, deficiency |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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