Interpretability of the Quantra® Viscoelastic Test in Patients with Haematological Malignancies with Profound Thrombocytopenia Below 50x10 G/L. (VISCOTHEM-1)

Interpretability of the Quantra® Viscoelastic Test in Patients with Haematological Malignancies with Profound Thrombocytopenia Below 50 G/L. First Exploratory Sub-study of the Global VISCOTHEM Project to Evaluate the Performance of VISCOelastic Tests in Predicting Bleeding in Thrombocytopenic Patients with Malignant Hemopathy.

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 Overview

• Status: Completed
• Conditions: Hematologic Malignancies; Thrombopenia
• Intervention / Treatment: Other: Blood sample

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Annecy, France
    • Centre Hospitalier Annecy Genevois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Intervention (additional blood sample)

Other: Blood sample; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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®.	At baseline, before platelet transfusion
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.	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®.	At baseline, before platelet transfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the correlation between ROTEM® results and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.	Correlation coefficients (r²) and its 95% confidence interval (IC95) between patients' platelet levels obtained in conventional biology and the following measurements obtained in ROTEM® : MCFextem; MCFfibtem; CTextem; MCEplatelets With MCEplatelets = [(100 × MCFextem)/(100 - MCFextem)] - [(100 × MCFfibtem)/(100 - MCFfibtem)]	At baseline, before 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.	Stratify correlation analyses and their r² coefficients (IC95) on thrombocytopenia depth into three groups: 0 to 9 G/L; 10 to 19 G/L; 20 to 49 G/L	At baseline, before platelet transfusion
To assess the correlation between Quantra® or ROTEM® results and platelet levels in the subpopulations of interest: patients with bleeding and patients without bleeding.	Stratify correlation analyses and their r² coefficients (IC95) on the presence or absence of bleeding at inclusion.	At baseline, before platelet transfusion
Evaluate the correlation between Quantra® and ROTEM® results.	Matrix of correlation coefficients (r²) and IC95 between Quantra® and ROTEM® values.	At baseline, before platelet transfusion
Describe changes in Quantra®, ROTEM® and other hemostasis parameters after platelet transfusion in thrombocytopenic patients transfused as part of routine care.	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.	Immediately after platelet transfusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Annecy Genevois
• Investigators: Principal Investigator: Adrien CONTEJEAN, Annecy Genevois Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Actual): December 6, 2024
• Study Completion (Actual): December 6, 2024

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Neoplasms by Site; Hematologic Diseases; Blood Platelet Disorders; Neoplasms; Hematologic Neoplasms; Thrombocytopenia
• Other Study ID Numbers: 24-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No