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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06455553
Other study ID # 24-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 17, 2024
Est. completion date December 17, 2024

Study information

Verified date June 2024
Source Centre Hospitalier Annecy Genevois
Contact Marion GHIDI
Phone +33450637031
Email mghidi@ch-annecygenevois.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date December 17, 2024
Est. primary completion date December 17, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Annecy Genevois

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the correlation between Quantra® (Clot firmness) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L. Correlation coefficient (r²) and its 95% confidence interval (IC95) between patients' platelet levels obtained by conventional biology and Clot firmness (CS) obtained with Quantra®. At baseline, before platelet transfusion
Primary Evaluate the correlation between Quantra® (Platelet contribution to clot) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L. Correlation coefficient (r²) and its 95% confidence interval (IC95) between patients' platelet levels obtained by conventional biology and Platelet contribution to clot (PCS) obtained with Quantra®. At baseline, before platelet transfusion
Secondary Evaluate the correlation between ROTEM® results and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L. Correlation coefficients (r²) and its 95% confidence interval (IC95) between patients' platelet levels obtained in conventional biology and the following measurements obtained in ROTEM® :
MCFextem
MCFfibtem
CTextem
MCEplatelets With MCEplatelets = [(100 × MCFextem)/(100 - MCFextem)] - [(100 × MCFfibtem)/(100 - MCFfibtem)]
At baseline, before platelet transfusion
Secondary Evaluate the correlation between Quantra® or ROTEM® results and platelet levels in the subpopulations of interest: patients with 0 to 9 G/L, 10 to 19 G/L and 20 to 49 G/L platelets. Stratify correlation analyses and their r² coefficients (IC95) on thrombocytopenia depth into three groups:
0 to 9 G/L
10 to 19 G/L
20 to 49 G/L
At baseline, before platelet transfusion
Secondary To assess the correlation between Quantra® or ROTEM® results and platelet levels in the subpopulations of interest: patients with bleeding and patients without bleeding. Stratify correlation analyses and their r² coefficients (IC95) on the presence or absence of bleeding at inclusion. At baseline, before platelet transfusion
Secondary Evaluate the correlation between Quantra® and ROTEM® results. Matrix of correlation coefficients (r²) and IC95 between Quantra® and ROTEM® values. At baseline, before platelet transfusion
Secondary Describe changes in Quantra®, ROTEM® and other hemostasis parameters after platelet transfusion in thrombocytopenic patients transfused as part of routine care. Quantitative evolution of Quantra® (CS and PCS), ROTEM® (MCFextem MCFfibtem, CTextem, MCEplatelets), plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen, hemoglobinemia, hematocrit and platelet count, immature platelets, leukocytes, neutrophils before and 1 hour after platelet transfusion. Immediately after platelet transfusion
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