Clinical Trial

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

Study acronym: VISCOTHEM-2
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
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.
Trial Details
NCT Number NCT07653672
Lead Sponsor Centre Hospitalier Annecy Genevois
Conditions Thrombocytopenia, Platelet Transfusion, Haemorrhage, Hematologic Malignancies
Enrollment 410 participants
Start Date 2026-06-30
Primary Completion 2028-07-15 (estimated)
Study Completion 2028-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-17