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โ† Trials
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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

Recruitingn/aAges 18 Years - anyAllCentre Hospitalier Annecy Genevois
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ 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 volum

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Additional blood sample
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Where

1 site
CH Annecy Genevois
ร‰pagny, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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