Clinical trial NCT06585930: Relation Between the Value of Platelet Clot Stiffness (PCS) Obtained by Sonorheometric Method of Delocalized Hemostasis (QUANTRA®), and the Presence of a Disorder of Primary Hemostasis, in Cardiac Surgery Patients. PLAQUA-Study
Official title: Study of the Relationship Between the Value of PCS (Platelet Clot Stiffness - Parameter Evaluating Platelet Participation in Clot Formation) Obtained by Sonorheometric Method of Delocalized Hemostasis (QUANTRA®), and the Presence of a Disorder of Primary Hemostasis, in Cardiac Surgery Patients. PLAQUA-Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Haemostasis Disorder in Cardiac Surgery Patients
Keywords: Primary haemostasis disorder
Platelet Clot Stiffness
QUANTRA
von Willebrand factor deficiency
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Patients

* Hospitalized for scheduled cardiac surgery performed under extracorporeal circulation, including coronary bypass, valve replacement, aortic arch and combined surgeries.

Exclusion Criteria:

Patients:

* with preoperative hematocrit \< 35% and preoperative platelet count \< 80,000 G/L (validity of PFA-200® Test)
* With known congenital or acquired Willebrand's disease, or known platelet dysfunction.
* On double antiaggregation, not discontinued at the time of surgery
* Vulnerable patients: minors or protected adults, pregnant women, patients not affiliated to the social security system.
* Emergency situation

Primary outcomes:
measure: Presence of a primary haemostasis disorder
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: University Hospital of Reunion Island - Cardiac reanimation department
state: Reunion
Study officials:
affiliation: University Hospital of Reunion Island
name: Margot CARON, Dr
role: PRINCIPAL_INVESTIGATOR
References: