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NCT06585930: PLAQUA

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

Completed Last updated 29 May 2025
What this trial tests

trial testing Blood sample in Primary Haemostasis Disorder in Cardiac Surgery Patients in 100 participants. Completed in 4 April 2025.

Timeline
30 August 2024
Primary endpoint
4 April 2025
4 April 2025

Quick facts

Lead sponsorCentre Hospitalier Universitaire de la Réunion
StatusCompleted
Study typeOBSERVATIONAL
Enrollment100
Start date30 August 2024
Primary completion4 April 2025
Estimated completion4 April 2025
Sites1 location across Reunion

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire de la Réunion

Who can join

18 and older, any sex, with Primary Haemostasis Disorder in Cardiac Surgery Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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