- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07653672
Role of Viscoelastometric Testing in the Development and Validation of a Clinical-biological Score for Predicting Bleeding in Patients With Malignant Haematological Disorders and Severe Thrombocytopenia (VISCOTHEM-2)
The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is To develop and validate a clinical-biological score (VISCOTHEM score) incorporating viscoelastometric tests parameters; based on an association study, and to establish a threshold that enables the prediction of the immediate risk of bleeding in haematology patients with severe thrombocytopenia (<20 G/L); with a view to selecting a population with a residual risk of bleeding of zero (NPV ≥ 95%, to achieve a residual probability of bleeding < 5%).
The score may incorporate variables identified in the literature as having a plausible causal relationship with the occurrence of bleeding (14,15), as well as viscoelastometric tests parameters, conventional haemostasis parameters and relevant clinical parameters. .
Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 21.1 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, urea, creatinin, albumin.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Marion GHIDI
- Número de telefone: +33450637031
- E-mail: mghidi@ch-annecygenevois.fr
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
The patients included will be selected from the entire cohort of patients with haematological malignancies:
- those admitted to the haematology day unit for treatment or assessment,
- or patients admitted to the haematology inpatient ward,
- or patients being monitored in the haematology outpatient clinic.
Descrição
Inclusion Criteria:
- Adult patients;
- Who have been informed about the study and have freely given their informed consent to participate in the study;
- With a malignant haematological disorder or bone marrow failure, whether treated or untreated and at any stage of treatment;
- With central thrombocytopenia strictly below 20 G/L in a blood sample taken less than 72 hours ago and not having received a transfusion since;
- Admitted to a haematology day unit or inpatient ward, or being followed up at a haematology outpatient clinic;
- With or without active bleeding;
- Affiliated with or covered by a social security scheme.
Exclusion Criteria:
- Patients who have received at least one of the following treatments:
- Antiplatelet agents within 7 days prior to enrolment,
- Vitamin K antagonists within 7 days prior to enrolment,
- Direct oral anticoagulants within 72 hours prior to enrolment,
- Low molecular weight heparin within 24 hours prior to inclusion,
- Unfractionated heparin within 6 hours prior to inclusion,
- Bruton's tyrosine kinase inhibitor (ibrutinib, zanubrutinib or acalabrutinib) within 72 hours prior to inclusion;
- Patients with a history of thrombopathy;
- Patients with a history of haemostatic disorders carrying a risk of haemorrhage or thrombosis;
- Thrombocytopenia associated with immune thrombocytopenic purpura or disseminated intravascular coagulation;
- Patients already enrolled in the study;
- Pregnant or breastfeeding women;
- Patients under guardianship or curatorship;
- Patients who do not understand French;
- Patients under judicial protection.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Intervention (additional 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 21.1 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, Urea, Creatinine, Albumin.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Identification of factors associated with bleeding among clinical and laboratory parameters
Prazo: At baseline, before platelet transfusion
|
Clinical parameters : Age, Sex, BMI, systolic and diastolic blood pressure, presence of mucositis, presence of a lesion with haemorrhagic potential, bleeding within the previous 5 days, fever associated with an infection or an episode of febrile neutropenia, transplant within the previous 100 days Laboratory parameters : viscoelastic test parameters, white blood cell count, Haemoglobin, Platelet and immature platelet counts, Urea, Creatinine, Albumin, Standard haemostasis (APTT, INR, Fibrinogen)
|
At baseline, before platelet transfusion
|
|
Apply a multivariate regression model to develop the VISCOTHEM score for predicting immediate bleeding (WHO score ≥ 1), based on the coefficients of the factors associated with bleeding
Prazo: At baseline, before platelet transfusion
|
At baseline, before platelet transfusion
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Stratification and comparison of performance and score calibration depending on whether the viscoelastic test result is obtained using ROTEM® or Quantra®.
Prazo: At baseline, before platelet transfusion
|
To propose a score capable of processing a viscoelastic test result from either ROTEM® or Quantra®,
|
At baseline, before platelet transfusion
|
|
Describe the presence of bleeding according to the WHO classification (WHO score ≥1) and WHO bleeding grade, where applicable
Prazo: 72 hours after blood sample
|
72 hours after blood sample
|
|
|
Describe the presence of platelet transfusion
Prazo: 72 hours after blood sample
|
72 hours after blood sample
|
|
|
Describe the Vital status or loss of follow-up, where applicable
Prazo: 72 hours after blood sample
|
72 hours after blood sample
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 24-10
- 2026-A00535-46 (Outro identificador: ID-RCB (ANSM))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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