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

NCT07653672 | Not Yet Recruiting

• 2 other identifiers: 24-102026-A00535-46
• Study Type: observational
• Target: 410
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Thrombocytopenia; Platelet Transfusion; Haemorrhage; Hematologic Malignancies

Keywords

viscoelasticity test; thrombocytopenia; haematologic disease; risk of bleeding; clinical and laboratory score

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Stratification and comparison of performance and score calibration depending on whether the viscoelastic test result is obtained using 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

Study Arms (1)

Intervention (additional blood sample)

Intervention (additional blood sample)

Biological: Additional blood sample

Interventions

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.

Intervention (additional blood sample)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

MeSH Terms

Conditions

Thrombocytopenia; Hemorrhage; Hematologic Neoplasms; Hematologic Diseases

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hemic and Lymphatic Diseases; Cytopenia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Central Study Contacts

Marion GHIDI

CONTACT

+33450637031; mghidi@ch-annecygenevois.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 15, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share