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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (additional blood sample) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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® :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrien CONTEJEAN | Annecy Genevois Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Annecy Genevois | Annecy | France |
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|
| 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:
| 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 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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