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Completed

NCT Number: 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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Reunion Island - Cardiac reanimation department

Saint-Denis, Reunion, 97400

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

Additional 8.1 ml blood sample

Primary outcomes

  1. Presence of a primary haemostasis disorder

    Time frame: Two years

    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®.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study 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

Acronym: PLAQUA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.