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

NCT06585930 | Completed

• 1 other identifier: 2024-A01342-45
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Haemostasis Disorder in Cardiac Surgery Patients

Keywords

Primary haemostasis disorder; Platelet Clot Stiffness; QUANTRA; von Willebrand factor deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Blood sample BIOLOGICAL

Additional 8.1 ml blood sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

University Hospital of Reunion Island - Cardiac reanimation department

Saint-Denis, Réunion, 97400, Reunion

Location

MeSH Terms

Conditions

Von willebrand factor, deficiency

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Margot CARON, Dr

  University Hospital of Reunion Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 19, 2024
• Study Start: August 30, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)