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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thrombocytopenia; Hematologic Malignancies; Haemorrhage; Platelet Transfusion
• Intervention / Treatment: Biological: Additional blood sample

• Study Type: Observational
• Enrollment (Estimated): 410

Contacts and Locations

• Study Contact: Name: Marion GHIDI; Phone Number: +33450637031; Email: mghidi@ch-annecygenevois.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Intervention (additional blood sample)

Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Annecy Genevois

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2028

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: thrombocytopenia; viscoelasticity test; haematologic disease; risk of bleeding; clinical and laboratory score
• Additional Relevant MeSH Terms: Cytopenia; Pathologic Processes; Neoplasms by Site; Neoplasms; Blood Platelet Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Thrombocytopenia; Hematologic Diseases; Hemorrhage
• Other Study ID Numbers: 24-10; 2026-A00535-46 (Other Identifier: ID-RCB (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No