- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01940523
Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in the topical arm of the study, prior to the release of the tourniquet they will receive 3 grams of tranexamic acid in 75ccs of solution directly on the site of the incision.
The primary result measurement will be blood drain output from the knee at 24 hours after surgery.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55902
- Mayo Clinic
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New York
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New York, New York, Estados Unidos, 10021
- Hospital for Special Surgery
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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:
- Primary total knee replacmeent
- Osteoarthritis
- Unilateral
Exclusion Criteria:
- Revision surgery
- Donated preoperative autologous blood
- On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
- Preoperative hepatic or renal dysfunction
- Diagnosis of inflammatory disease
- Diagnosis of inflammatory arthritis
- Pregnant
- Breastfeeding
- Preoperative hemoglobin <10g/dL
- International Normalized Ratio>1.4
- Abnormal Partial Thromboplastin Time
- Preoperative platelet count of <150,000mm^3
- Creatinine > 1.4
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Topical Tranexamic Acid
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution).
This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
The solution will be left in contact with the tissues for five minutes.
The surgeon will suction away excess solution.
The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes.
After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.
|
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution).
This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
The solution will be left in contact with the tissues for five minutes.
The surgeon will suction away excess solution.
The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes.
After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.
|
Comparador activo: Intravenous Tranexamic Acid
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet.
A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
|
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet.
A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Total Blood Loss
Periodo de tiempo: during surgery
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The amount of blood lost during surgery is the primary outcome measure.
Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.
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during surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Drain Output
Periodo de tiempo: from end of surgery to 24 hours postoperatively
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The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery.
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from end of surgery to 24 hours postoperatively
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The Number Patients Requiring a Transfusion
Periodo de tiempo: over course of hospital stay (averaging three days)
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TThe number Patients requiring a transfusion over the course of the patient's hospital stay.
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over course of hospital stay (averaging three days)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David Mayman, MD, Hospital for Special Surgery, New York
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 (Estimar)
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
- 12166
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