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

Not Applicable

Completed

• Conditions: Hematologic Malignancies; Thrombopenia
• Interventions: Other: Blood sample

• Registration Number: NCT06455553
• Lead Sponsor: Centre Hospitalier Annecy Genevois

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-12
• Study Start: 2024-06-26
• Primary Completion: 2024-12-06
• Study Completion: 2024-12-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention (additional blood sample)	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Evaluate the correlation between Quantra® (Clot firmness) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.	At baseline, before platelet transfusion	Correlation coefficient (r²) and its 95% confidence interval (IC95) between patients' platelet levels obtained by conventional biology and Clot firmness (CS) obtained with Quantra®.
Evaluate the correlation between Quantra® (Platelet contribution to clot) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.	At baseline, before platelet transfusion	Correlation coefficient (r²) and its 95% confidence interval (IC95) between patients' platelet levels obtained by conventional biology and Platelet contribution to clot (PCS) obtained with Quantra®.

Secondary Outcome Measures

Name	Time	Method
To assess the correlation between Quantra® or ROTEM® results and platelet levels in the subpopulations of interest: patients with bleeding and patients without bleeding.	At baseline, before platelet transfusion	Stratify correlation analyses and their r² coefficients (IC95) on the presence or absence of bleeding at inclusion.
Evaluate the correlation between Quantra® and ROTEM® results.	At baseline, before platelet transfusion	Matrix of correlation coefficients (r²) and IC95 between Quantra® and ROTEM® values.
Evaluate the correlation between ROTEM® results and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.	At baseline, before platelet transfusion	Correlation coefficients (r²) and its 95% confidence interval (IC95) between patients' platelet levels obtained in conventional biology and the following measurements obtained in ROTEM® : 1. MCFextem; 2. MCFfibtem; 3. CTextem; 4. MCEplatelets With MCEplatelets = \[(100 × MCFextem)/(100 - MCFextem)\] - \[(100 × MCFfibtem)/(100 - MCFfibtem)\]
Describe changes in Quantra®, ROTEM® and other hemostasis parameters after platelet transfusion in thrombocytopenic patients transfused as part of routine care.	Immediately after platelet transfusion	Quantitative evolution of Quantra® (CS and PCS), ROTEM® (MCFextem MCFfibtem, CTextem, MCEplatelets), plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen, hemoglobinemia, hematocrit and platelet count, immature platelets, leukocytes, neutrophils before and 1 hour after platelet transfusion.
Evaluate the correlation between Quantra® or ROTEM® results and platelet levels in the subpopulations of interest: patients with 0 to 9 G/L, 10 to 19 G/L and 20 to 49 G/L platelets.	At baseline, before platelet transfusion	Stratify correlation analyses and their r² coefficients (IC95) on thrombocytopenia depth into three groups: 1. 0 to 9 G/L; 2. 10 to 19 G/L; 3. 20 to 49 G/L

Trial Locations

Locations (1)

Centre Hospitalier Annecy Genevois; 🇫🇷 Annecy, France