El ensayo SyNAPSe estudiará si la administración de progesterona por vía intravenosa (i.v.) dentro de las 8 horas posteriores a la lesión, durante un total de 120 horas, mejora la recuperación de pacientes con traumatismo craneoencefálico grave.

Elegibilidad

Edad mínima: 16 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Male or female patients between the age of 16 and 70 years, inclusive
Weight from 45 to 135 kg, inclusive
Sustained a closed head trauma no more than 8 hours before start of study drug infusion
TBI diagnosed by history and clinical examination
Post-resuscitation Glasgow Coma Scale (GCS) score between 3 to 8, inclusive
At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive)
Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
Indication for ICP monitoring

Criterios de exclusión

Life expectancy of less than 24 hours as determined by the Investigator
Prolonged and/or uncorrectable hypoxia (Pa02\< 60 mmHg) or hypotension (systolic blood pressure \< 90 mmHg) at the time of randomization
Any spinal cord injury
Pregnancy
Penetrating head injury
Bilaterally fixed dilated pupils at the time of randomization
Coma suspected to be primarily due to other causes (e.g. alcohol)
Pure epidural hematoma
Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome
Severe cardiac or hemodynamic instability prior to randomization
Known treatment with another investigational drug therapy or procedure within 30 days of injury
A history of allergic reaction to progesterone and related drugs or any of the components of the infusion
Any disease, in the opinion of the Investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol through the final visit (6 months post-injury)

Intervenciones

drug

Progesterone

Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

drug

Lipid emulsion without progesterone

Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

Ubicaciones

Hospital Francisco Lopez Lima

General Roca, Río Negro Province, Argentina

Hospital de Emergencias Clemente Alvarez (HECA)

Rosario, Santa Fe Province, Argentina

Hospital Nacional "Profesor Alejandro Posadas"

Buenos Aires, Argentina

Hospital Regional De Comodoro Rivadavia (HRCR)

Comodoro Rivadavia, Argentina

Hospital Central de Mendoza

Mendoza, Argentina

Hospital San Martin

Paraná, Argentina

Hospital Dr. José Maria Cullen

Santa Fé, Argentina

Estudio de Fase 3 Aleatorizado, Doble Ciego, Controlado con Placebo para Investigar la Eficacia y Seguridad de la Progesterona en Pacientes con Traumatismo Craneoencefálico Grave

Resumen