Hematologic Malignancies Clinical Trial
— VISCOTHEM-1Official 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.
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Centre Hospitalier Annecy Genevois |
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 |
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