A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters
Colección de datos
Enfermedades Cardiovasculares
+ Enfermedades Vasculares
+ Trombosis
Resumen
Fecha de inicio: 1 de enero de 1996
Fecha en la que se inscribió al primer participante.The Groshong and Groshong PICC catheters are popular venous access devices because they are maintained with only weekly saline flushes. In a recent study, however, we found an apparent decrease in the rate of withdrawal occlusion in Groshong catheters flushed weekly with heparinized saline. However, a randomized trial is necessary to confirm this impression. In the current study as many as 66 patients will be randomized to each of two treatment arms. The Groshong catheters of one group will be flushed with saline only and the other group with heparinized saline. A comparison will be made between the frequency with which urokinase is used in the two groups to treat withdrawal occlusion during the first three months of catheterization. Groshong catheters using saline flushes will be compared to Groshong catheters using heparinized saline flushes and Groshong PICC catheters using saline flushes will be compared to Groshong PICC catheters using heparinized saline flushes. Data will be analyzed using Fisher's exact test.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 132 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Adult subjects enrolled in approved protocols of the NCI in the CC or under treatment at the National Naval Medical Center who are planned to have Groshong Catheters used as part of their cancer treatment. No subjects with a history of allergy to heparin. No abnormal PT or PTT. No subjects on anticoagulant therapy. No history of heparin induced thrombocytopenia.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Warren G. Magnuson Clinical Center (CC)
Bethesda, United StatesAbrir Warren G. Magnuson Clinical Center (CC) en Google Maps