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Interpretability of the Quantra® Viscoelastic Test in Patients with Haematological Malignancies with Profound Thrombocytopenia Below 50x10 G/L. (VISCOTHEM-1)

C

Centre Hospitalier Annecy Genevois

Status

Completed

Conditions

Thrombopenia
Hematologic Malignancies

Treatments

Other: Blood sample

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

Intervention (additional blood sample)
Other group
Treatment:
Other: Blood sample

Trial contacts and locations

1

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Central trial contact

Marion GHIDI

Data sourced from clinicaltrials.gov

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