Asociación del uso profiláctico de fármacos para las úlceras por estrés y los resultados clínicos en pacientes con trombectomía aguda de la circulación anterior
Asociación del uso profiláctico de fármacos para las úlceras por estrés y los resultados clínicos en pacientes con trombectomía aguda de la circulación anterior: un estudio de cohorte prospectivo, multicéntrico y observacional
Ischemic stroke accounts for a relatively high proportion of strokes. In recent years, intravenous thrombolysis and endovascular therapy have significantly improved the revascularization rate in patients with large vessel occlusive cerebral infarction, but 20-50% of patients still experience ineffective revascularization. Therefore, postoperative monitoring and treatment of patients with large vessel occlusions is crucial for early recognition, management and prevention of complications. Stress ulcer bleeding is a serious complication after acute ischemic stroke, with a prevalence of 1%-5%, and a previously proven incidence of stress ulcer bleeding after ischemic stroke. Stress ulcer bleeding after ischemic stroke has been shown to be closely associated with unfavorable outcomes, such as mortality. Current national and international guidelines or consensus on the prevention of stress ulcers after acute ischemic stroke do not advocate the routine use of histamine receptor antagonists or proton pump inhibitors for the prevention of stress ulcers, but rather should be considered in the context of the patient's risk factors for stress ulcers and discontinued after the patient initiates enteral nutrition. However, there is no evidence-based medical evidence to support the risk-benefit relationship of stress ulcer drug prophylaxis in patients with mechanical thrombectomy for acute anterior circulation large vessel occlusion.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Descripción detallada
Stress ulcer bleeding is a serious complication after acute ischemic stroke, with a prevalence of 1%-5%, of which only 0.5%-1% require blood transfusion or result in hypotension. Stress ulcer bleeding after ischemic stroke has been shown to be associated with poor outcomes, such as mortality, and basilar artery occlusion and middle cerebral artery cerebral infarction are independent risk factors for stress ulcer bleeding after acute ischemic stroke. Guidelines or consensus on the prevention of stress ulcers after acute ischemic stroke do not advocate the routine use of histamine receptor antagonists or proton pump inhibitors for stress ulcer prevention.
However, stress ulcer prophylaxis is initiated in most patients admitted to the neurological intensive care unit after mechanical embolization of acute anterior circulation large vessel occlusion. With advances such as diagnosis and early initiation of enteral nutrition, the rate of stress ulcer bleeding in patients with mechanical embolization of acute anterior circulation large vessel occlusion is significantly reduced. The relationship between the risk and benefit of SUP in patients undergoing mechanical embolization for acute anterior circulation large vessel occlusion is not yet supported by evidence-based medical evidence. Therefore, the purpose of this study was to investigate the correlation between pharmacological stress ulcer prophylaxis and clinical outcomes in patients undergoing mechanical thrombectomy for acute anterior circulation large vessel occlusion.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Suyue Pan, M.D., Ph.D.
- Número de teléfono: 13556184981
- Correo electrónico: pansuyue@smu.edu.cn
Ubicaciones de estudio
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Fujian
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Fuzhou, Fujian, Porcelana
- Reclutamiento
- Fujian Medical University Union Hospital
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Contacto:
- Shenggen Chen, M.D.
- Número de teléfono: 13459480275
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Guangdong
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Dongguan, Guangdong, Porcelana
- Reclutamiento
- Dongguan People's Hospital
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Contacto:
- Zhu Shi, M.D.
- Número de teléfono: 13669825459
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Dongguan, Guangdong, Porcelana
- Reclutamiento
- Dongguan donghua hospital
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Contacto:
- Lingyu Sun
- Número de teléfono: 13829203368
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Guangzhou, Guangdong, Porcelana
- Reclutamiento
- Nanfang Hospital of Southern Medical University
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Contacto:
- Suyue Pan
- Número de teléfono: 13556184981
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Guangzhou, Guangdong, Porcelana
- Reclutamiento
- Guangdong Provincial Hospital of Traditional Chinese Medicine
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Contacto:
- Lixin Wang, M.D.
- Número de teléfono: 13922793886
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Guangzhou, Guangdong, Porcelana
- Reclutamiento
- Huadu District People's Hospital of Guangzhou
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Contacto:
- Guangning Li, M.D.
- Número de teléfono: 13926239656
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Guangzhou, Guangdong, Porcelana
- Reclutamiento
- The Fourth Affiliated Hospital of Guangzhou Medical University
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Contacto:
- Wangchi Luo, M.D.
- Número de teléfono: 13710895142
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Heyuan, Guangdong, Porcelana
- Reclutamiento
- Heyuan people's Hospital
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Contacto:
- Minzhen Zhu
- Número de teléfono: 15007622318
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Huizhou, Guangdong, Porcelana
- Reclutamiento
- Huizhou Municipal Central Hospital
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Contacto:
- Lizhi Wang, M.D.
- Número de teléfono: 13802872076
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Hainan
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Haikou, Hainan, Porcelana
- Reclutamiento
- Hainan Provincial People's Hospital
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Contacto:
- Fan Zhang, M.D.
- Número de teléfono: 17389897580
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Haikou, Hainan, Porcelana
- Reclutamiento
- Haikou People's Hospital
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Contacto:
- Guoshuai Yang, M.D.
- Número de teléfono: 13876006248
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Haikou, Hainan, Porcelana
- Reclutamiento
- Hainan Traditional Chinese Medicine Hospital
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Contacto:
- Yong Gu, M.D.
- Número de teléfono: 15521280288
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Hunan
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Changsha, Hunan, Porcelana
- Reclutamiento
- The First Hospital of Changsha
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Contacto:
- Xu Peng, M.D。
- Número de teléfono: 15802507292
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Hengyang, Hunan, Porcelana
- Reclutamiento
- The Second Hospital University of South China
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Contacto:
- Yanhong Hu, M.D.
- Número de teléfono: 13265004191
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Yueyang, Hunan, Porcelana
- Reclutamiento
- Yueyang People's Hospital
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Contacto:
- Yuan Zhou, M.D.
- Número de teléfono: 15107309796
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Inner Mongolia
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Baotou, Inner Mongolia, Porcelana
- Reclutamiento
- Sinopharm North Hospital
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Contacto:
- Lifei Xing, M.D
- Número de teléfono: 15354919958
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Hohhot, Inner Mongolia, Porcelana
- Reclutamiento
- The Affiliated Hospital of Inner Mongolia Medical University
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Contacto:
- Lihua Sun, M.D.
- Número de teléfono: 18686292585
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Jiangxi
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Ganzhou, Jiangxi, Porcelana
- Reclutamiento
- Ganzhou City People's Hospital
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Contacto:
- Zhaohui Lai
- Número de teléfono: 13879729792
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Zhejiang
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Wenzhou, Zhejiang, Porcelana
- Reclutamiento
- Second Affiliated Hospital of Wenzhou Medical University
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Contacto:
- Saijun Zhou, M.D.
- Número de teléfono: 13857746659
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients who are treated with mechanical thrombectomy with acute anterior circulation large vessel occlusion. ≥18 years of age, within 24 hours of onset. Expected survival >3 months. NIHSS score ≥ 6 at onset of illness.
Descripción
Inclusion Criteria:
- Age ≥18 years.
- Within 24 hours of onset. Meet the criteria for diagnosis of acute ischemic stroke in the "China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018".
- Meet the indications for mechanical thrombectomy in the "Chinese Guidelines for Early Endovascular Interventions in Acute Ischemic Stroke 2022".
- Treated with mechanical thrombectomy.
- NIHSS score ≥ 6 at onset of illness.
- Sign an informed notice.
Exclusion Criteria:
Allergy to drug ingredients. Women who are pregnant or breastfeeding. Life expectancy of less than 3 months due to other non-ischemic stroke diseases such as malignancy, severe liver or renal failure.
Have participated in other interventional clinical studies (affecting the outcome of this cohort study).
Participants who were judged by the investigator to be unsuitable for participation in this study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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Stress Ulcer Prophylaxis
Subjects are on stress ulcer medications including PPIs, H2RBs, and mucosal protectors at 24 h of admission. |
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Control Group
Subjects are not on stress ulcer medications including PPIs, H2RBs, and mucosal protectors at 24 h of admission. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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90-day mortality after onset
Periodo de tiempo: 90-day after onset
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Proportion of enrolled patients who died 90 days after onset of disease. |
90-day after onset
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Incidence of stroke-associated pneumonia
Periodo de tiempo: within 7-day of onset
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Incidence of non-mechanically ventilated stroke patients with new pneumonia within 7-day of onset |
within 7-day of onset
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of clinically significant bleeding
Periodo de tiempo: within 7-day of onset
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One of the following 4 symptoms occurs within 24 hours of bleeding from a stress ulcer (in the absence of other causes):1. A decrease of ≥ 20 mmHg in any one of systolic, diastolic and mean arterial pressure. 2.Initiation of blood pressure boosters or 20% increase in medication dose.3. Decreased hemoglobin ≥ 2 g/d(（1.24 mmol/l). 4.Infusion of erythrocytes ≥ 2 U. |
within 7-day of onset
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Incidence of stress ulcer bleeding
Periodo de tiempo: 7-day after onset
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Coffee-like residue/black stool/blood in stool within 7-day after onset and more than 2 consecutive positive fecal/gastric fluid occult blood |
7-day after onset
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Incidence of unfavorable functional prognosis at 90 days after onset
Periodo de tiempo: 90-day after onset
|
Incidence of unfavorable functional prognosis at 90 days after onset |
90-day after onset
|
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90-day mRS score change
Periodo de tiempo: 90-day after onset
|
Modified Rankin Scale score change within 90 days after onset in patients who were eligible for inclusion criteria |
90-day after onset
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Incidence of early neurological deterioration
Periodo de tiempo: within 72 hours after onset
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Increased score of National Institutes of Health Stroke Scale within 72h after onset ≥ 4 |
within 72 hours after onset
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1-year post-onset mortality
Periodo de tiempo: 1 year after onset
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Mortality at 1 year after onset in patients who were eligible for inclusion criteria |
1 year after onset
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Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset
Periodo de tiempo: 1 year after onset
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Incidence of adverse related events such as pneumonia or myocardial ischemia 1 year after onset in patients who were eligible for inclusion criteria |
1 year after onset
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Suyue Pan, Department of Neurology, Nanfang Hospital,Southern Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- NFEC-2023-040
Información sobre medicamentos y dispositivos, documentos del estudio
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