Health Condition 1: null- Traumatic Brain Injury (TBI)
Conditions
Interventions
Intervention1: Progesterone: Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
Other Name: BHR-100
Intervention2: Lipid e
Sponsors
BHR Pharma
PRA International
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients, age between 16 and 70 years, inclusive (or lower age limit as required by local regulations) 2.Weight from 45 to 135 kg, inclusive. 3.Sustained a closed head trauma no more than 8 hours before initiation of study drug infusion 4.TBI diagnosed by history and clinical examination 5.Post-resuscitation GCS score between 4 to 8, inclusive 6.At least one reactive pupil 7.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) 8.Indication for ICP monitoring
Exclusion criteria
Exclusion criteria: 1.Life expectancy of less than 24 hours as determined by the Investigator 2.Prolonged and/or uncorrectable hypoxia (Pa02< 60 mmHg) or hypotension (systolic blood pressure < 90 mmHg) upon admission. 3.Any spinal cord injury 4.Pregnancy 5.Penetrating head injury 6.Bilaterally fixed dilated pupils at the time of randomization 7.Coma suspected to be primarily due to other causes (e.g. alcohol) 8.Pure epidural hematoma 9.Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome 10.Severe cardiac or hemodynamic instability after resuscitation 11.Known treatment with another investigational drug therapy or procedure within 30 days of injury. 12.A history of allergic reaction to progesterone and related drugs or any of the components of the infusion 13.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. 14.Subjects 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GOS evaluation.Timepoint: 6 months post injury. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of GOSTimepoint: At 3 months;Evaluation of the GOS-ETimepoint: At 3 and 6 months;Mortality assessmentTimepoint: At 1 month and 6 months post TBI;Quality of Life (SF-36)Timepoint: At 3 and 6 months | — |
Countries
Austria, Belgium, China, Czech Republic, Germany, Hungary, India, Israel, Italy, Netherlands, Romania, Singapore, Spain, Taiwan, United Kingdom, United States of America
Contacts
Public ContactMr Robert Fernandez
PRA International
Outcome results
None listed