Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585930
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLAQUA
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 100GL andor 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 81ml 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
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 100GL andor 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 81ml 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None