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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Annecy Genevois

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Additional blood sample

Treatment groups

410 Participants
are divided into 1 treatment group

Locations

This trial has no locations