Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula

Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula

Patrocinadores

Patrocinador principal: First Affiliated Hospital of Chongqing Medical University

Fuente First Affiliated Hospital of Chongqing Medical University
Resumen breve

Many guidelines at home and abroad advocate that arteriovenous fistula should be the first choice of permanent vascular access, but it is easy to form thrombus in a short time after arteriovenous fistula molding, resulting in internal fistula stenosis or occlusion. In this study, the investigators plan to screen the patients with arteriovenous fistula in the blood purification center of our hospital. Through the study design of random grouping and open label, the investigators will discuss the use of low molecular weight heparin or warfarin to prevent thrombosis in a short period of time after arteriovenous fistula operation. According to the research results, the investigators will understand efficacy and safety of short-term postoperative anticoagulant therapy to prevente thrombosis in arterovenous fistula.

Estado general Recruiting
Fecha de inicio January 1, 2019
Fecha de Terminación October 1, 2020
Fecha de finalización primaria June 1, 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Blood flow of arteriovenous fistula up to 6 months
arteriovenous fistula dysfunction or occlusion up to 6 months
Active bleeding events up to 6 months
arteriovenous fistula dysfunction or occlusion up to 6 months
Resultado secundario
Medida Periodo de tiempo
coagulation index up to 6 months
Platelet up to 6 months
Number of hospitalization up to 6 months
Inscripción 110
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Low molecular weight heparin

Descripción: patients began to use low molecular weight heparin or warfarin sodium tablets.

Etiqueta de grupo de brazo: anticoagulant therapy group

Otro nombre: warfarin sodium tablets

Tipo de intervención: Other

Nombre de intervención: non anticoagulant therapy group

Descripción: no anticoagulant was used after operation.

Etiqueta de grupo de brazo: non anticoagulant therapy group

Elegibilidad

Criterios:

Inclusion Criteria:

- the participants were treated with autogenous arteriovenous fistula, reconstruction and balloon dilatation;

- stable health, compliant with treatment, and active following treatment. Exclusion Criteria.

- age > 85 years old;

- history of blood system diseases;

- history of familial and hereditary bleeding diseases;

- important complications affecting the coagulation system, such as liver diseases;

- abnormal coagulation function and active bleeding;

- history of intracranial and digestive tract bleeding, obvious skin stasis;

- complications, such as surgery and tumor, which significantly increase the risk of bleeding;

- no subjective will.

Género: All

Edad mínima: 20 Years

Edad máxima: 85 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Hua Gan, Dr. Study Director First Affiliated Hospital of Chongqing Medical University
Contacto general

Apellido: Yunfeng Xia, Dr.

Teléfono: 86-23-89012256

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: The First Affiliated Hospital of Chongqing Medical University Yunfeng Xia, Dr. 86-23-89012256 [email protected]
Ubicacion Paises

China

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: First Affiliated Hospital of Chongqing Medical University

Nombre completo del investigador: Yunfeng Xia

Título del investigador: Clinical Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: anticoagulant therapy group

Tipo: Experimental

Descripción: during hospitalization, patients began to use low molecular weight heparin subcutaneously after arteriovenous fistula operation, once or twice a day, 4000iu-8000iu a day. After discharge, the patients took warfarin sodium tablets orally, 1.25mg on dialysis day, 2.5mg on non dialysis day, for a total course of 4 weeks.

Etiqueta: non anticoagulant therapy group

Tipo: Other

Descripción: no anticoagulant was used after operation, but both groups could take antiplatelet drugs.

Acrónimo EASOAT
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: we plan to recruite the patients with arteriovenous fistula in the blood purification center of our hospital. After recruitment, the patients were randomly assigned to anticoagulant therapy group or non anticoagulant therapy group. anticoagulant therapy group: during hospitalization, patients began to use low molecular weight heparin subcutaneously after arteriovenous fistula operation, once or twice a day, 4000iu-8000iu a day. After discharge, the patients took warfarin sodium tablets orally, 1.25mg on dialysis day, 2.5mg on non dialysis day, for a total course of 4 weeks. non anticoagulant therapy group: no anticoagulant was used after operation, but both groups could take antiplatelet drugs.Efficacy and safety of short-term postoperative anticoagulant therapy to prevente thrombosis were evaluated.

Propósito primario: Prevention

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov