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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-A00535-46 | Other Identifier | ID-RCB (ANSM) |
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The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is To develop and validate a clinical-biological score (VISCOTHEM score) incorporating viscoelastometric tests parameters; based on an association study, and to establish a threshold that enables the prediction of the immediate risk of bleeding in haematology patients with severe thrombocytopenia (<20 G/L); with a view to selecting a population with a residual risk of bleeding of zero (NPV ≥ 95%, to achieve a residual probability of bleeding < 5%).
The score may incorporate variables identified in the literature as having a plausible causal relationship with the occurrence of bleeding (14,15), as well as viscoelastometric tests parameters, conventional haemostasis parameters and relevant clinical parameters. .
Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 21.1 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, urea, creatinin, albumin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (additional blood sample) | Intervention (additional blood sample) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional blood sample | Biological | 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 21.1 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, Urea, Creatinine, Albumin. |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of factors associated with bleeding among clinical and laboratory parameters | Clinical parameters : Age, Sex, BMI, systolic and diastolic blood pressure, presence of mucositis, presence of a lesion with haemorrhagic potential, bleeding within the previous 5 days, fever associated with an infection or an episode of febrile neutropenia, transplant within the previous 100 days Laboratory parameters : viscoelastic test parameters, white blood cell count, Haemoglobin, Platelet and immature platelet counts, Urea, Creatinine, Albumin, Standard haemostasis (APTT, INR, Fibrinogen) | At baseline, before platelet transfusion |
| Apply a multivariate regression model to develop the VISCOTHEM score for predicting immediate bleeding (WHO score ≥ 1), based on the coefficients of the factors associated with bleeding | At baseline, before platelet transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Stratification and comparison of performance and score calibration depending on whether the viscoelastic test result is obtained using ROTEM® or Quantra®. | To propose a score capable of processing a viscoelastic test result from either ROTEM® or Quantra®, | At baseline, before platelet transfusion |
| Describe the presence of bleeding according to the WHO classification (WHO score ≥1) and WHO bleeding grade, where applicable |
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Inclusion Criteria:
Exclusion Criteria:
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The patients included will be selected from the entire cohort of patients with haematological malignancies:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion GHIDI | Contact | +33450637031 | mghidi@ch-annecygenevois.fr |
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|
| 72 hours after blood sample |
| Describe the presence of platelet transfusion | 72 hours after blood sample |
| Describe the Vital status or loss of follow-up, where applicable | 72 hours after blood sample |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D006470 | Hemorrhage |
| D019337 | Hematologic Neoplasms |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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