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

Hematologic Malignancies Clinical Trial

— VISCOTHEM-1  

Official 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455553
• Other study ID #: 24-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2024
• Est. completion date: December 17, 2024

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Annecy Genevois
• Contact: Marion GHIDI
• Phone: +33450637031
• Email: mghidi[@]ch-annecygenevois.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 17, 2024
• Est. primary completion date: December 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Neoplasms
• Thrombocytopenia
• Thrombopenia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Annecy Genevois

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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