Phase III Randomized, Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury
methylprednisolone
+ tirilazad
Enfermedades del Sistema Nervioso Central+7
+ Enfermedades del sistema nervioso
+ Procesos Patológicos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1991
Fecha en la que se inscribió al primer participante.PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. Patients are randomly assigned to 1 of 3 treatment groups within 6 hours of injury. Treatment begins within 2 hours of randomization. One group receives a 24-hour methylprednisolone (MePRDL) infusion: a loading dose followed in 45 minutes by a 23-hour continuous infusion. A placebo for tirilazad is also administered. A second group receives the same MePRDL loading dose but the continuous infusion is maintained for 48 hours. A placebo for tirilazad is also administered. A third group receives a 48-hour infusion of tirilazad with an initial bolus dose of MePRDL. Eight additional doses of tirilazad are administered by intravenous push. The MePRDL loading dose may be omitted for patients who received a prestudy MePRDL dose. Patients are followed at 72 hours, 6 weeks, 6 months, and 1 year after the injury.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 497 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
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.A partir de 14 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Acute spinal cord injury; diagnosis confirmed by study physician using National Acute Spinal Cord Injury Study neurologic exam Glasgow Coma Score greater than 9 Randomization within 6 hours of injury required; treatment must begin within 8 hours of injury No root involvement only; no cauda equina only --Prior/Concurrent Therapy-- Methylprednisolone bolus (20-40 mg/kg) prior to hospital admission allowed --Patient Characteristics-- Hematopoietic: No hematologic contraindication to protocol therapy Cardiovascular: No vascular contraindication to protocol therapy Other: No diabetes; No gunshot wound; No gastrointestinal bleeding; No life-threatening co-morbidity; No other medical contraindication to protocol therapy; No pregnant women; No patients under indictment or incarcerated; No conditions that would complicate follow-up, e.g.: out-of-state residency or illegal alien status