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临床试验/NCT06585930
NCT06585930已完成不适用

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

Centre Hospitalier Universitaire de la Réunion1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月30日最近更新:
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试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Presence of a primary haemostasis disorder

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Presence of a primary haemostasis disorder

时间窗: 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®.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (1)

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