Clinical trial NCT06455553: Interpretability of the Quantra® Viscoelastic Test in Patients With Haematological Malignancies With Profound Thrombocytopenia Below 50x10 G/L.
Official title: Interpretability of the Quantra® Viscoelastic Test in Patients With Haematological Malignancies With Profound Thrombocytopenia Below 50 G/L. First Exploratory Sub-study of the Global VISCOTHEM Project to Evaluate the Performance of VISCOelastic Tests in Predicting Bleeding in Thrombocytopenic Patients With Malignant Hemopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Malignancies
Thrombopenia
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: Evaluate the correlation between Quantra® (Clot firmness) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.
timeFrame: At baseline, before platelet transfusion
measure: 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.
timeFrame: At baseline, before platelet transfusion
Secondary outcomes:
measure: Evaluate the correlation between ROTEM® results and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.
timeFrame: At baseline, before platelet transfusion
measure: 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.
timeFrame: At baseline, before platelet transfusion
measure: To assess the correlation between Quantra® or ROTEM® results and platelet levels in the subpopulations of interest: patients with bleeding and patients without bleeding.
timeFrame: At baseline, before platelet transfusion
measure: Evaluate the correlation between Quantra® and ROTEM® results.
timeFrame: At baseline, before platelet transfusion
measure: Describe changes in Quantra®, ROTEM® and other hemostasis parameters after platelet transfusion in thrombocytopenic patients transfused as part of routine care.
timeFrame: Immediately after platelet transfusion
Other outcomes:
Locations:
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois
Study officials:
affiliation: Annecy Genevois Hospital
name: Adrien CONTEJEAN
role: PRINCIPAL_INVESTIGATOR
References: