- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07582341
Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy
The Role of Tranexamic Acid Combined Dose Intravenous and in Irrigation Fluid in Optimizing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled and Double-blind Study
Percutaneous nephrolithotomy is a minimally invasive surgical procedure used to remove large kidney stones. Although it is an effective treatment, bleeding during and after the procedure remains one of the main concerns and may sometimes require blood transfusion.
Tranexamic acid is a medication that helps reduce bleeding by limiting the breakdown of blood clots. It can be given through a vein and may also be used locally in irrigation fluid during surgery. This study evaluates whether using tranexamic acid by both routes during percutaneous nephrolithotomy can reduce blood loss, improve the clarity of the surgical field during endoscopy, and reduce the need for blood transfusion.
The study included adult patients with kidney stones larger than two centimeters who were suitable for percutaneous nephrolithotomy. Patients were randomly assigned to receive either tranexamic acid through a vein and in the irrigation fluid, or normal saline as a control treatment. Blood loss was assessed using hemoglobin and hematocrit levels before and after surgery, as well as hemoglobin concentration in the irrigation fluid collected at the end of the operation. The surgeon also assessed the clarity of the surgical field using a ten-point visual scale.
The hypothesis of the study is that combined intravenous and local administration of tranexamic acid in irrigation fluid during percutaneous nephrolithotomy reduces blood loss, improves surgical visibility, and lowers the need for blood transfusion compared with normal saline.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, Egipto, 13511
- Benha University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients aged 18 to 70 years.
- Patients with renal stones larger than 2 centimeters.
- Patients scheduled for percutaneous nephrolithotomy.
- Normal renal function, defined as serum creatinine less than or equal to 1.5 milligrams per deciliter.
- American Society of Anesthesiologists physical status class 1 or 2.
Exclusion Criteria:
- Hypersensitivity to tranexamic acid.
- Pregnancy.
- Current anticoagulation therapy.
- Untreated urinary tract infection or urosepsis.
- Renal anatomical anomalies, including ectopic kidney, duplex collecting system, or horseshoe kidney.
- Solitary functioning kidney.
- Decompensated coagulopathy or known hematological disease.
- Acute or chronic renal disease.
- History of cerebrovascular events or thromboembolism.
- Uncontrolled arrhythmia.
- Morbid obesity.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Combined Tranexamic Acid Group
Participants in this arm received tranexamic acid 10 milligrams per kilogram intravenously in 250 milliliters normal saline 15 minutes before induction of anesthesia, in addition to the same dose of tranexamic acid added to the first 4 liters of irrigation fluid during percutaneous nephrolithotomy.
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Tranexamic acid was administered as a combined intravenous and local intervention during percutaneous nephrolithotomy.
The intravenous dose was given before anesthesia induction, and the local dose was added to the initial irrigation fluid used during the procedure.
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Comparador de placebos: Normal Saline Control Group
Participants in this arm received 250 milliliters normal saline intravenously 15 minutes before induction of anesthesia, in addition to normal saline placebo added to the first 4 liters of irrigation fluid during percutaneous nephrolithotomy.
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Normal saline was used as the placebo comparator.
It was administered intravenously before anesthesia induction and added to the initial irrigation fluid during percutaneous nephrolithotomy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in hemoglobin concentration after percutaneous nephrolithotomy
Periodo de tiempo: Preoperative, immediate postoperative, and 24 hours postoperative
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Difference in hemoglobin concentration measured before surgery and after surgery to assess perioperative blood loss.
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Preoperative, immediate postoperative, and 24 hours postoperative
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in hematocrit concentration after percutaneous nephrolithotomy
Periodo de tiempo: Preoperative, immediate postoperative, and 24 hours postoperative
|
Difference in hematocrit concentration measured before surgery and after surgery as an additional indicator of perioperative blood loss.
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Preoperative, immediate postoperative, and 24 hours postoperative
|
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Need for blood transfusion
Periodo de tiempo: Intraoperatively and up to 24 hours postoperatively
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Number of participants who required blood transfusion during the intraoperative or postoperative hospital stay period.
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Intraoperatively and up to 24 hours postoperatively
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Hemoglobin concentration in irrigation fluid
Periodo de tiempo: At the end of surgery
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Hemoglobin concentration measured in the irrigation fluid collected at the end of surgery as an estimate of intraoperative blood loss.
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At the end of surgery
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Endoscopic surgical field visibility score
Periodo de tiempo: At the end of surgery
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Surgical field visibility was assessed by the operating surgeon using a 10-point visual scale.
The score ranges from 1 to 10, where 1 indicates very poor visibility and 10 indicates perfect visibility.
Higher scores indicate better endoscopic surgical field visibility.
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At the end of surgery
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Postoperative Hematuria
Periodo de tiempo: Up to 24 hours postoperatively
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Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Need for Additional Hemostatic Intervention
Periodo de tiempo: Up to 24 hours postoperatively
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Number of participants who required an additional intervention to control bleeding after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Postoperative Infection
Periodo de tiempo: Up to 24 hours postoperatively
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Number of participants who developed postoperative infection after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Postoperative Hematuria
Periodo de tiempo: Up to 24 hours postoperatively
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Number of participants with visible hematuria requiring continued nephrostomy tube closure or delayed nephrostomy tube removal.
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Up to 24 hours postoperatively
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Colaboradores e Investigadores
Patrocinador
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
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Cálculos
- Condiciones Patológicas, Anatómicas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Urolitiasis
- Cálculos urinarios
- Complicaciones intraoperatorias
- Condiciones Patológicas, Signos y Síntomas
- Cálculos renales
- Nefrolitiasis
- Hemorragia
- Pérdida De Sangre Quirúrgica
- Químicos orgánicos
- Preparaciones farmacéuticas
- Ácidos carboxílicos
- Soluciones cristaloides
- Soluciones isotónicas
- Soluciones
- Ácidos, carbocíclicos
- Ácidos ciclohexanecarboxílicos
- Ácido tranexámico
- Solución salina
Otros números de identificación del estudio
- MS 33-5-2025
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
- SAVIA
- CIF
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.
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