Interpretability of the Quantra® Viscoelastic Test in Patients With Haematological Malignancies With Profound Thrombocytopenia Below 50x10 G/L.

NCT ID: NCT06455553

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-26
• Study Completion Date: 2024-12-06

Brief Summary

The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is to evaluate the interpretability of viscoelastic tests (Quantra® and ROTEM® type) in relation to platelet levels measured in standard biology in patients with haematological malignancies, hospitalized in day hospitals or full hematology wards, presenting thrombocytopenia strictly below 50 G/L.

Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 12.1 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.

Conditions

Hematologic Malignancies; Thrombopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Intervention (additional blood sample)

Group Type: OTHER

Blood sample

Intervention Type: OTHER

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 12.1 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.

Interventions

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 12.1 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient age > 18 years old ;
• Patients who have been informed of the study and have freely given their informed consent to participate in the study;
• Patients with hematologic malignancies, treated or untreated, at any stage of treatment;
• Patient with thrombocytopenia strictly below 50 G/L on a blood sample taken less than 72 hours ago;
• Patient hospitalized in day hospitalization or in full hematology hospitalization;
• Patient covered by a French social security scheme.

Exclusion Criteria

• Patients treated with antiplatelet agents or anticoagulants in preventive or curative doses;
• Patient with a history of thrombopathy;
• Patient with a history of haemostasis pathology at risk of haemorrhage or thrombosis;
• Pregnant or breast-feeding patients;
• Patients under guardianship;
• Patients who do not understand French;
• Patients under court protection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Annecy Genevois

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrien CONTEJEAN

Role: PRINCIPAL_INVESTIGATOR

Annecy Genevois Hospital

Locations

Centre Hospitalier Annecy Genevois

Annecy, , France

Countries

France

Other Identifiers

24-01

Identifier Type: -

Identifier Source: org_study_id