- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03183479
The Effects of Fibrinogen Concentrate Infusion on Blood Loss and Allogeneic Blood Conservation in Scoliosis Surgery
The Effects of Fibrinogen Concentrate Infusion on Perioperative Blood Loss and Allogeneic Blood Conservation in Patients Undergoing Scoliosis Surgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, randomized, double-blinded, placebo controlled trial to evaluate the effects of fibrinogen concentrate infusion on perioperative blood loss and the amount of perioperative allogeneic blood transfusion in patients undergoing scoliosis surgery.
Recently, the inherent risks of blood, along with the continued rise in blood costs, activated the development and use of alternatives to blood transfusion. Fibrinogen concentrate may limit postoperative bleeding and lead to a significant reduction in allogeneic blood products transfusions in cardiac surgery and craniosynostosis surgery. However, the effect of fibrinogen concentrate in scoliosis surgery is still uncertain. Therefore, a prospective, randomized trial is designed to evaluate if the infusion of fibrinogen concentrate may reduce allogeneic blood transfusion in patients undergoing scoliosis surgery.
Patients older than 12y/o with adolescent idiopathic scoliosis planed for elective posterior scoliosis correction surgery will be enrolled for this study after informed consent. Patients will be randomly assigned to a treatment group or a control group. Functional fibrinogen will be measured using TEG 5000 (Haemoscope Corp, IL, USA) at the start of surgery and the results of FLEV and MA will be recorded. After pedicle screw placement, a second functional fibrinogen will be measured and the patients in treatment group will receive fibrinogen concentrate (FIBRORAAS, Shanghai RAAS Blood Products Co, Ltd, Shanghai, China) 30mg kg-1. For safety concern, the maximum fibrinogen concentrate administration for each individual shall not exceed either 2g. Patients in the control group will receive placebo treatment with normal saline. After 15 minutes from fibrinogen concentrate or placebo administration, a third functional fibrinogen measurement will be performed to assess the effect of treatment. The following treatment will be guaranteed by the standard protocol in the presence of ongoing bleeding.
Data includes all the demographics, preoperative conditions, procedure details, intraoperative data, and outcome measurements will be recorded. Additional data including FLEV and MA value, as well as fibrinogen values both preoperatively and at the arrival at wards. The primary endpoint of this study will be the total perioperative blood loss, and secondary endpoints will include: perioperative blood loss per fused level, intraoperative blood loss per fused level, the amount of postoperative drainage, the amount of postoperative drainage per fused level, total units of perioperative allogeneic pRBCs transfused, total volume of FFP transfused, total PLT units transfused. Safety endpoints will include operative mortality and perioperative thromboembolic complications.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100730
- Peking Union Medical College Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patients diagnosed as adolescent idiopathic scoliosis
- planed for elective posterior scoliosis correction surgery at Peking Union Medical College Hospital
Exclusion Criteria:
- preoperative anemia
- preoperative congenital or acquired coagulopathy
- ongoing anticoagulation therapy or drug intake that could cause bleeding
- clinical signs or diagnosis of acute thromboembolism
- emergency surgery
- redo surgery
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Treatment group
The patients in treatment group will receive Fibrinogen Concentrate Human administration.
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After start of surgery when all pedicle screws are placed, the patients in treatment group will receive fibrinogen concentrate 30mg kg-1.
For safety concern, functional fibrinogen will be measured and the maximum fibrinogen concentrate administration for each individual shall not exceed 2g.
Fibrinogen concentrate will be diluted in 100mL of sterile water and then be administered to patients.
Otros nombres:
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Comparador de placebos: Control group
The patients in control group will be administered with normal saline solution as placebo.
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100mL normal saline will be administered to patients in control group as placebo
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Perioperative blood loss
Periodo de tiempo: hospital stay up to 30 days
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the total amount of intraoperative and postoperative blood loss
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hospital stay up to 30 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Perioperative blood loss per fused level
Periodo de tiempo: hospital stay up to 30 days
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amount of intraoperative and postoperative blood loss divided by the number of surgical fused levels
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hospital stay up to 30 days
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Intraoperative blood loss
Periodo de tiempo: From the time of skin incision until wound closure, assessed up to 12 hours
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the amount of intraoperative blood loss
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From the time of skin incision until wound closure, assessed up to 12 hours
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Intraoperative blood loss per fused level
Periodo de tiempo: From the time of skin incision until wound closure, assessed up to 12 hour
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amount of intraoperative blood loss divided by the number of surgical fused levels
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From the time of skin incision until wound closure, assessed up to 12 hour
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Postoperative drainage
Periodo de tiempo: hospital stay up to 30 days
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the amount of postoperative drainage
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hospital stay up to 30 days
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Postoperative drainage per fused level
Periodo de tiempo: hospital stay up to 30 days
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amount of postoperative drainage divided by the number of surgical fused levels
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hospital stay up to 30 days
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Perioperative allogeneic red blood cell (RBC) transfusion
Periodo de tiempo: hospital stay up to 30 days
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total units of RBC transfused perioperatively
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hospital stay up to 30 days
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Perioperative plasma transfusion
Periodo de tiempo: hospital stay up to 30 days
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total volume of plasma transfused perioperatively
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hospital stay up to 30 days
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Perioperative platelets transfusion
Periodo de tiempo: hospital stay up to 30 days
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total units of platelets transfused perioperatively
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hospital stay up to 30 days
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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
- PUMCH-FC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Formulario de consentimiento informado (ICF)
- Informe de estudio clínico (CSR)
- Código analítico
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.
producto fabricado y exportado desde los EE. UU.
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