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Trial Title:
Interpretability of the Quantra® Viscoelastic Test in Patients With Haematological Malignancies With Profound Thrombocytopenia Below 50x10 G/L.
NCT ID:
NCT06455553
Condition:
Hematologic Malignancies
Thrombopenia
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Thrombocytopenia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Blood sample
Description:
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.
Arm group label:
Intervention (additional blood sample)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Annecy Genevois
Address:
City:
Annecy
Country:
France
Status:
Recruiting
Contact:
Last name:
Nadine CADOUX
Investigator:
Last name:
Adrien CONTEJEAN
Email:
Principal Investigator
Start date:
June 26, 2024
Completion date:
December 26, 2024
Lead sponsor:
Agency:
Centre Hospitalier Annecy Genevois
Agency class:
Other
Source:
Centre Hospitalier Annecy Genevois
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06455553
