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

Last updated: October 31, 2024
Sponsor: Centre Hospitalier Universitaire de la Réunion
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Blood sample

Clinical Study ID

NCT06585930
2024-A01342-45
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

Patients

  • Hospitalized for scheduled cardiac surgery performed under extracorporealcirculation, including coronary bypass, valve replacement, aortic arch and combinedsurgeries.

Exclusion

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 plateletdysfunction.

  • On double antiaggregation, not discontinued at the time of surgery

  • Vulnerable patients: minors or protected adults, pregnant women, patients notaffiliated to the social security system.

  • Emergency situation

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Blood sample
Phase:
Study Start date:
August 30, 2024
Estimated Completion Date:
August 30, 2025

Connect with a study center

  • University Hospital of Reunion Island - Cardiac reanimation department

    Saint-Denis, 97400
    Réunion

    Active - Recruiting

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