Role of Viscoelastometric Testing in the Development and Validation of a Clinical-biological Score for Predicting Bleeding in Patients With Malignant Haematological Disorders and Severe Thrombocytopenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 410
研究概览
简要总结
The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is To develop and validate a clinical-biological score (VISCOTHEM score) incorporating viscoelastometric tests parameters; based on an association study, and to establish a threshold that enables the prediction of the immediate risk of bleeding in haematology patients with severe thrombocytopenia (<20 G/L); with a view to selecting a population with a residual risk of bleeding of zero (NPV ≥ 95%, to achieve a residual probability of bleeding < 5%).
The score may incorporate variables identified in the literature as having a plausible causal relationship with the occurrence of bleeding (14,15), as well as viscoelastometric tests parameters, conventional haemostasis parameters and relevant clinical parameters. .
Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 21.1 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, urea, creatinin, albumin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Adult patients;
- •Who have been informed about the study and have freely given their informed consent to participate in the study;
- •With a malignant haematological disorder or bone marrow failure, whether treated or untreated and at any stage of treatment;
- •With central thrombocytopenia strictly below 20 G/L in a blood sample taken less than 72 hours ago and not having received a transfusion since;
- •Admitted to a haematology day unit or inpatient ward, or being followed up at a haematology outpatient clinic;
- •With or without active bleeding;
- •Affiliated with or covered by a social security scheme.
排除标准
- •Patients who have received at least one of the following treatments:
- •Antiplatelet agents within 7 days prior to enrolment,
- •Vitamin K antagonists within 7 days prior to enrolment,
- •Direct oral anticoagulants within 72 hours prior to enrolment,
- •Low molecular weight heparin within 24 hours prior to inclusion,
- •Unfractionated heparin within 6 hours prior to inclusion,
- •Bruton's tyrosine kinase inhibitor (ibrutinib, zanubrutinib or acalabrutinib) within 72 hours prior to inclusion;
- •Patients with a history of thrombopathy;
- •Patients with a history of haemostatic disorders carrying a risk of haemorrhage or thrombosis;
- •Thrombocytopenia associated with immune thrombocytopenic purpura or disseminated intravascular coagulation;
- •Patients already enrolled in the study;
- •Pregnant or breastfeeding women;
- •Patients under guardianship or curatorship;
- •Patients who do not understand French;
- •Patients under judicial protection.