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

NCT06455553 | Completed

• 1 other identifier: 24-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancies; Thrombopenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

• 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

• 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

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

  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.

  Immediately after platelet transfusion

Study Arms (1)

Intervention (additional blood sample)

OTHER

Other: Blood sample

Interventions

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.

Intervention (additional blood sample)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

Study Sites (1)

Centre Hospitalier Annecy Genevois

Annecy, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Thrombocytopenia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Platelet Disorders; Cytopenia

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Adrien CONTEJEAN

  Annecy Genevois Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 12, 2024
• Study Start: June 26, 2024
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)