Interpretability of the Quantra® Viscoelastic Test in Patients with Haematological Malignancies with Profound Thrombocytopenia Below 50 G/L. First Exploratory Sub-study of the Global VISCOTHEM Project to Evaluate the Performance of VISCOelastic Tests in Predicting Bleeding in Thrombocytopenic Patients with Malignant Hemopathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evaluate the correlation between Quantra® (Clot firmness) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.
研究概览
简要总结
The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is to evaluate the interpretability of viscoelastic tests (Quantra® and ROTEM® type) in relation to platelet levels measured in standard biology in patients with haematological malignancies, hospitalized in day hospitals or full hematology wards, presenting thrombocytopenia strictly below 50 G/L.
Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 12.1 mL. The following analyses will be performed: Quantra®, Rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age > 18 years old ;
- •Patients who have been informed of the study and have freely given their informed consent to participate in the study;
- •Patients with hematologic malignancies, treated or untreated, at any stage of treatment;
- •Patient with thrombocytopenia strictly below 50 G/L on a blood sample taken less than 72 hours ago;
- •Patient hospitalized in day hospitalization or in full hematology hospitalization;
- •Patient covered by a French social security scheme.
排除标准
- •Patients treated with antiplatelet agents or anticoagulants in preventive or curative doses;
- •Patient with a history of thrombopathy;
- •Patient with a history of haemostasis pathology at risk of haemorrhage or thrombosis;
- •Pregnant or breast-feeding patients;
- •Patients under guardianship;
- •Patients who do not understand French;
- •Patients under court protection.
结局指标
主要结局
Evaluate the correlation between Quantra® (Clot firmness) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.
时间窗: At baseline, before platelet transfusion
Correlation coefficient (r²) and its 95% confidence interval (IC95) between patients' platelet levels obtained by conventional biology and Clot firmness (CS) obtained with Quantra®.
Evaluate the correlation between Quantra® (Platelet contribution to clot) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.
时间窗: At baseline, before platelet transfusion
Correlation coefficient (r²) and its 95% confidence interval (IC95) between patients' platelet levels obtained by conventional biology and Platelet contribution to clot (PCS) obtained with Quantra®.
次要结局
- To assess the correlation between Quantra® or ROTEM® results and platelet levels in the subpopulations of interest: patients with bleeding and patients without bleeding.(At baseline, before platelet transfusion)
- Evaluate the correlation between Quantra® and ROTEM® results.(At baseline, before platelet transfusion)
- Evaluate the correlation between ROTEM® results and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.(At baseline, before platelet transfusion)
- Describe changes in Quantra®, ROTEM® and other hemostasis parameters after platelet transfusion in thrombocytopenic patients transfused as part of routine care.(Immediately after platelet transfusion)
- Evaluate the correlation between Quantra® or ROTEM® results and platelet levels in the subpopulations of interest: patients with 0 to 9 G/L, 10 to 19 G/L and 20 to 49 G/L platelets.(At baseline, before platelet transfusion)