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

Обзор

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.

Вмешательства

• Биопрепарат 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.

Первичные конечные точки

• Identification of factors associated with bleeding among clinical and laboratory parameters [Срок оценки: 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 [Срок оценки: At baseline, before platelet transfusion]

Вторичные конечные точки (4)

• Stratification and comparison of performance and score calibration depending on whether the viscoelastic test result is obtained using ROTEM® or Quantra®. [Срок оценки: At baseline, before platelet transfusion]
• Describe the presence of bleeding according to the WHO classification (WHO score ≥1) and WHO bleeding grade, where applicable [Срок оценки: 72 hours after blood sample]
• Describe the presence of platelet transfusion [Срок оценки: 72 hours after blood sample]
• Describe the Vital status or loss of follow-up, where applicable [Срок оценки: 72 hours after blood sample]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07653672 · 24-10 · 2026-A00535-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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