Clinical trial · Observational
Role of Viscoelastometric Testing in the Development and Validation of a Clinical-biological Score for Predicting Bleeding in Patients With Malignant Haematological Disorders and Severe Thrombocytopenia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Haemorrhage | — | UNRESOLVED | — |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Platelet Transfusion | — | UNRESOLVED | — |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional blood sample | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Intervention (additional blood sample)
- description
- Intervention (additional blood sample)
- interventionNames
- Biological: Additional blood sample
Primary outcomes (2)
- measure
- Identification of factors associated with bleeding among clinical and laboratory parameters
- timeFrame
- At baseline, before platelet transfusion
- description
- 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)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients; * Who have been informed about the study and have freely given their informed consent to participate in the study; * With a malignant haematological disorder or bone marrow failure, whether treated or untreated and at any stage of treatment; * With central thrombocytopenia strictly below 20 G/L in a blood sample taken less than 72 hours ago and not having received a transfusion since; * Admitted to a haematology day unit or inpatient ward, or being followed up at a haematology outpatient clinic; * With or without active bleeding; * Affiliated with or covered by a social security scheme. Exclusion Criteria: * Patients who have received at least one of the following treatments: * Antiplatelet agents within 7 days prior to enrolment, * Vitamin K antagonists within 7 days prior to enrolment, * Direct oral anticoagulants within 72 hours prior to enrolment, * Low molecular weight heparin within 24 hours prior to inclusion, * Unfractionated heparin within 6 hours prior to inclusion, * Bruton's tyrosine kinase inhibitor (ibrutinib, zanubrutinib or acalabrutinib) within 72 hours prior to inclusion; * Patients with a history of thrombopathy; * Patients with a history of haemostatic disorders carrying a risk of haemorrhage or thrombosis; * Thrombocytopenia associated with immune thrombocytopenic purpura or disseminated intravascular coagulation; * Patients already enrolled in the study; * Pregnant or breastfeeding women; * Patients under guardianship or curatorship; * Patients who do not understand French; * Patients under judicial protection.
References
Publications (0)
Data not yet available