- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05058521
Venous thromboEmbolism Risk Profiles in Chinese hoSpitalized patiEnts (VERSE Study)
Venous Thromboembolism Risk Profiles Among Hospitalized Patients in Chinese General Hospital- a Cross-sectional Single-institution Based Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
In this study, the investigators recruited adult inpatients attending Tsinghua Chang Gung Hospital in Beijing from June 2018 to April 2020, screened for patients with a hospital stay over 3 days and new-onset of VTE during hospital stay, and identified the in-hospital VTE patients after excluding patients who presented for DVT and/or PE. Similarly, negative patients were selected by not having a VTE during hospital stay. The diagnosis of VTE was confirmed as the occurrence of a critical value alert during hospitalization, which was predefined as ultrasound/radiology report of DVT or/and PE. Data was collected from the TEACH database of Beijing Tsinghua Chang Gung Hospital affiliated with Tsinghua University.
Patients baseline characteristics were extracted from database. VTE risk assessment was conducted with either Caprini risk assessment model (surgical patients) or Padua prediction score (medical patients). The evaluation was started upon admission and regularly repeated depending on the patient's condition. The last evaluation was conducted before discharge. The D-dimer values during hospitalization were also collected.
The rate of in-hospital VTE, distributions of in-hospital VTE patients and the receiver operating characteristic curves were analyzed.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing, Porcelana, 102218
- Beijing Tsinghua Chang Gung Hosipital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 18 and over, male or female
- Inpatients with a hospital stay over 3 days
- With or without new-onset of VTE during their stay
Exclusion Criteria:
- Patients who presented for DVT and/or PE
- Patients who were admitted in emergency department
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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In-hospital VTE group
In-hospital VTE group includes patients who were with a hospital stay over 3 days and new-onset of VTE during their stay.
Patients who presented for VTE were excluded.
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Negative group
Negative group includes patients who were with a hospital stay over 3 days and did not have a VTE during their hospital stay.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The rate of in-hospital VTE
Periodo de tiempo: From June 2018 to April 2020
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The diagnosis of VTE was confirmed as the occurrence of a critical value alert during hospitalization, which was predefined as ultrasound/radiology report of DVT or/and PE.
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From June 2018 to April 2020
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Caprini risk assessment model scores
Periodo de tiempo: Through discharge, an average of 20 days
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Patients were stratified of VTE risk as very low risk (0), low risk (1-2), medium risk (3-4), high risk (5 and over).
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Through discharge, an average of 20 days
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Padua prediction score scores
Periodo de tiempo: Through discharge, an average of 20 days
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Patients were stratified of VTE risk as low risk (0-3) and high risk (4 and over).
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Through discharge, an average of 20 days
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D-dimer values
Periodo de tiempo: Through discharge, an average of 20 days
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The upper normal value 0.55mg/L FEU was used.
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Through discharge, an average of 20 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Weiwei Wu, MD, Beijing Tsinghua Chang Gung Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 19242-4-01
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.
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