- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00795743
Coagulation Changes in Trauma Patients
The Effect of Central Venous Catheters on Systemic Coagulation
Descripción general del estudio
Estado
Condiciones
Descripción detallada
We will enroll all patients who will be getting a Central Venous Catheter (CVC) placed either in the PICC Insertion Room or in a surgical intensive care unit who are undergoing emergent central venous catheter placement for a medically indicated reason. All patients who have not had a previous central line or will be getting their catheter exchanged over guide wire are eligible.
At Baseline:
We intend to evaluate the patient for a Deep Vein Thrombosis by conducting a duplex ultrasound of the lower extremities prior to line insertion. We will also collect one sample of blood at baseline within 3 hours of insertion.
During CVC Insertion:
One sample of blood will be collected during CVC insertion.
Follow Up:
The last blood sample will be collected soon after CVC insertion (approximately 3hrs). Blood samples will only be drawn when we are available to collect them. Thus, this is defined as a "sample of convenience". We will also conduct another duplex ultrasound of the extremities after CVC insertion for evaluation of DVT.
Data will be collected on the duplex ultrasound result, the type of central line and the exact insertion site. Should a DVT be found, the attending physician will be made aware according to clinical protocol.
Normally, at the moment of central venous puncture, 5cc of blood is aspirated and wasted to confirm correct placement of the needle tip before placement of the guidewire. For the intended study, instead of wasting that blood, we will save 500 microliters of it for coagulation analysis. Immediately after the catheter is inserted over the guidewire, a chest x-ray is obtained to verify position of the catheter. At this point, each port of the central venous catheter is aspirated and wasted before infusion through the central venous catheter. For the purpose of this study, we will save 500 microliters of that wasted blood for coagulation analysis. To clarify, the second 500 microliters will be drawn through the newly placed central venous catheter ports and saved (instead of being drawn and wasted). Drawing back on each port before infusing is standard practice. This second sample will contain a small amount of saline, but, based on a few trials in the animal lab, this saline is unlikely to effect the coagulation analysis.
In summary, we intend to visit the patient 3 times over approximately a 4 hour period for the purpose of collecting blood that would normally otherwise be wasted (a total of 1500 microliters). This will be done only on patients who are undergoing the procedure for for a medically indicated reason and medical care will not be changed, affected, or otherwise altered based on involvement in this study. Our purpose is simply to collect 3 samples of blood during emergent central venous catheter placement that would otherwise be wasted into the biohazard container.
We will use this blood to assay prothrombin time, partial thromboplastin time, thromboelastography, Prothrombin Fragment 1.2, Factor VIII, and VonWillebrand's Factor.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Miami, Florida, Estados Unidos, 33136
- Ryder Trauma Center
-
-
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:
- All patients undergoing placement of a central venous catheter.
Exclusion Criteria:
- Age under 18 or known coagulation disorder (inherited or pharmacologic).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Coagulopathy
Periodo de tiempo: 3 hours surrounding placement of catheter
|
3 hours surrounding placement of catheter
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kenneth G Proctor, PhD, University of Miami
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 20070692
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. .