Interpretability of the Quantra® Viscoelastic Test in Patients With Haematological Malignancies With Profound Thrombocytopenia Below 50x10 G/L.

Centre Hospitalier Annecy Genevois48 enrolled

Overview

The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is to evaluate the interpretability of viscoelastic tests (Quantra® and ROTEM® type) in relation to platelet levels measured in standard biology in patients with haematological malignancies, hospitalized in day hospitals or full hematology wards, presenting thrombocytopenia strictly below 50 G/L. Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 12.1 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Hematologic Malignancies Thrombopenia

Interventions

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 12.1 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient age \> 18 years old ; * Patients who have been informed of the study and have freely given their informed consent to participate in the study; * Patients with hematologic malignancies, treated or untreated, at any stage of treatment; * Patient with thrombocytopenia strictly below 50 G/L on a blood sample taken less than 72 hours ago; * Patient hospitalized in day hospitalization or in full hematology hospitalization; * Patient covered by a French social security scheme. Exclusion Criteria: * Patients treated with antiplatelet agents or anticoagulants in preventive or curative doses; * Patient with a history of thrombopathy; * Patient with a history of haemostasis pathology at risk of haemorrhage or thrombosis; * Pregnant or breast-feeding patients; * Patients under guardianship; * Patients who do not understand French; * Patients under court protection.

Outcomes

Primary Outcomes

Evaluate the correlation between Quantra® (Clot firmness) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.

Correlation coefficient (r²) and its 95% confidence interval (IC95) between patients' platelet levels obtained by conventional biology and Clot firmness (CS) obtained with Quantra®.