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NCT Number: NCT06455553

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

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.

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Key information

Conditions

Hematologic Malignancies Blood Platelet Disorders Cytopenia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Thrombocytopenia Thrombopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Annecy Genevois

Annecy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

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.

Primary outcomes

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

    Time frame: 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®.

  2. 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.

    Time frame: 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 outcomes

  1. Evaluate the correlation between ROTEM® results and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.

    Time frame: 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® :

    • MCFextem
    • MCFfibtem
    • CTextem
    • MCEplatelets With MCEplatelets = [(100 × MCFextem)/(100 - MCFextem)] - [(100 × MCFfibtem)/(100 - MCFfibtem)]

  2. 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.

    Time frame: At baseline, before platelet transfusion

    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

  3. To assess the correlation between Quantra® or ROTEM® results and platelet levels in the subpopulations of interest: patients with bleeding and patients without bleeding.

    Time frame: At baseline, before platelet transfusion

    Stratify correlation analyses and their r² coefficients (IC95) on the presence or absence of bleeding at inclusion.

  4. Evaluate the correlation between Quantra® and ROTEM® results.

    Time frame: At baseline, before platelet transfusion

    Matrix of correlation coefficients (r²) and IC95 between Quantra® and ROTEM® values.

  5. Describe changes in Quantra®, ROTEM® and other hemostasis parameters after platelet transfusion in thrombocytopenic patients transfused as part of routine care.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Annecy Genevois

Other

Registry information

Official study title

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.

Acronym: VISCOTHEM-1

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 12, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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