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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 (VISCOTHEM-2)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Marion GHIDI
- Telefoonnummer: +33450637031
- E-mail: mghidi@ch-annecygenevois.fr
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
The patients included will be selected from the entire cohort of patients with haematological malignancies:
- those admitted to the haematology day unit for treatment or assessment,
- or patients admitted to the haematology inpatient ward,
- or patients being monitored in the haematology outpatient clinic.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Intervention (additional 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 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Identification of factors associated with bleeding among clinical and laboratory parameters
Tijdsspanne: At baseline, before platelet transfusion
|
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
Tijdsspanne: At baseline, before platelet transfusion
|
At baseline, before platelet transfusion
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Stratification and comparison of performance and score calibration depending on whether the viscoelastic test result is obtained using ROTEM® or Quantra®.
Tijdsspanne: At baseline, before platelet transfusion
|
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
Tijdsspanne: 72 hours after blood sample
|
72 hours after blood sample
|
|
|
Describe the presence of platelet transfusion
Tijdsspanne: 72 hours after blood sample
|
72 hours after blood sample
|
|
|
Describe the Vital status or loss of follow-up, where applicable
Tijdsspanne: 72 hours after blood sample
|
72 hours after blood sample
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 24-10
- 2026-A00535-46 (Andere identificatie: ID-RCB (ANSM))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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