- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07656311
Mean Platelet Volume (MPV) as an Early Predictor of Mortality in Intensive Care Patients With Cancer (MPV-CICU)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This retrospective, observational, single-center study will evaluate the predictive value of initial Mean Platelet Volume (MPV) and other hemogram parameters (such as Red Cell Distribution Width [RDW] and platelet count) on intensive care and hospital mortality. The primary objective is to investigate the correlation between these routinely measured, cost-effective biomarkers and survival outcomes in oncological critical care patients. The study hypotheses are structured as follows:
- H0: There is no significant relationship between the admission MPV value and intensive care or hospital mortality in intensive care patients with cancer.
- H1: There is a significant relationship between the admission MPV value and intensive care or hospital mortality in intensive care patients with cancer. Data regarding demographics (age, sex), clinical diagnoses, comorbidities, length of stay, APACHE II, SOFA scores, and laboratory parameters (CRP, procalcitonin) will be extracted from hospital electronic database records. All patient data will be anonymized before statistical analysis.
Note on Study Design: This study is designed as a retrospective cohort study. Due to system registry constraints in the protocol module, the time perspective has been specified as 'Other' (Retrospective Cohort).
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ankara, Turquía (Türkiye)
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adult patients aged 18 years and older.
- Patients with a pathologically or clinically confirmed diagnosis of cancer (solid or hematological malignancies).
- Patients who were admitted to the Anesthesia Intensive Care Unit (ICU) between 2020 and 2025.
- Patients with an ICU length of stay longer than 24 hours.
- Patients with complete medical records, including baseline complete blood count (CBC) and Mean Platelet Volume (MPV) measured at the time of ICU admission.
Exclusion Criteria:
- Patients under the age of 18.
- Patients who stayed in the intensive care unit for less than 24 hours.
- Patients with missing or incomplete medical charts, laboratory data, or survival status records.
- Patients who were readmitted to the ICU during the same hospital stay (only the first admission will be evaluated).
- Patients who received massive blood or platelet transfusions immediately prior to the baseline laboratory measurement, which could artificially alter platelet parameters.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Oncological ICU Patients
Adult patients (aged 18 and older) with a confirmed cancer diagnosis who were admitted to the anesthesia intensive care unit for longer than 24 hours between the years 2020 and 2025
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intensive Care Unit (ICU) Mortality
Periodo de tiempo: From the date of ICU admission up to ICU discharge, assessed up to 30 days.
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The percentage of oncological patients who died during their stay in the anesthesia intensive care unit.
This will be calculated based on the electronic health records and patient files.
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From the date of ICU admission up to ICU discharge, assessed up to 30 days.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hospital Mortality
Periodo de tiempo: From the date of hospital admission up to hospital discharge, assessed up to 60 days.
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The percentage of oncological patients who died during their overall hospital stay (including post-ICU ward follow-up).
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From the date of hospital admission up to hospital discharge, assessed up to 60 days.
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-05/106
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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