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.
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;
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,
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.
Cohort
Prospective
Additional blood sample
Biological/VaccineA 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.
Identification of factors associated with bleeding among clinical and laboratory parameters
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)
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
Stratification and comparison of performance and score calibration depending on whether the viscoelastic test result is obtained using ROTEM® or Quantra®.
To propose a score capable of processing a viscoelastic test result from either ROTEM® or Quantra®,
Describe the presence of bleeding according to the WHO classification (WHO score ≥1) and WHO bleeding grade, where applicable
Describe the presence of platelet transfusion
Describe the Vital status or loss of follow-up, where applicable
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