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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 (VISCOTHEM-2)

2026年6月16日 更新者:Centre Hospitalier Annecy Genevois

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.

研究概览

研究类型

观察性的

注册 (估计的)

410

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The patients included will be selected from the entire cohort of patients with haematological malignancies:

  • those admitted to the haematology day unit for treatment or assessment,
  • or patients admitted to the haematology inpatient ward,
  • or patients being monitored in the haematology outpatient clinic.

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Intervention (additional blood sample)
A blood sample will be taken from all patients included in the study. This blood sampling is an added act of the study. It will be performed as soon as possible after inclusion in the study. 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, Creatinine, Albumin.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Identification of factors associated with bleeding among clinical and laboratory parameters
大体时间:At baseline, before platelet transfusion
Clinical parameters : Age, Sex, BMI, systolic and diastolic blood pressure, presence of mucositis, presence of a lesion with haemorrhagic potential, bleeding within the previous 5 days, fever associated with an infection or an episode of febrile neutropenia, transplant within the previous 100 days Laboratory parameters : viscoelastic test parameters, white blood cell count, Haemoglobin, Platelet and immature platelet counts, Urea, Creatinine, Albumin, Standard haemostasis (APTT, INR, Fibrinogen)
At baseline, before platelet transfusion
Apply a multivariate regression model to develop the VISCOTHEM score for predicting immediate bleeding (WHO score ≥ 1), based on the coefficients of the factors associated with bleeding
大体时间:At baseline, before platelet transfusion
At baseline, before platelet transfusion

次要结果测量

结果测量
措施说明
大体时间
Stratification and comparison of performance and score calibration depending on whether the viscoelastic test result is obtained using ROTEM® or Quantra®.
大体时间:At baseline, before platelet transfusion
To propose a score capable of processing a viscoelastic test result from either ROTEM® or Quantra®,
At baseline, before platelet transfusion
Describe the presence of bleeding according to the WHO classification (WHO score ≥1) and WHO bleeding grade, where applicable
大体时间:72 hours after blood sample
72 hours after blood sample
Describe the presence of platelet transfusion
大体时间:72 hours after blood sample
72 hours after blood sample
Describe the Vital status or loss of follow-up, where applicable
大体时间:72 hours after blood sample
72 hours after blood sample

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月30日

初级完成 (估计的)

2028年7月15日

研究完成 (估计的)

2028年7月15日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月16日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月16日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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