Health Condition 1: null- Severe Traumatic Brain Injury
Conditions
Interventions
Intervention1: Progesterone Injection: 1.0mg/kg via intramuscular injection and then once every 12 hours for 5 consecutive days.
Control Intervention1: Distilled Water: 1.0mg/kg via intramuscular inje
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients, age between 16 and 70 years, inclusive 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, Marshallâ??s CT Classification)
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.Patients with 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.Pre-existing 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.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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glasgow Outcome Scale (GOS)ScoreTimepoint: At 6 month post injury | — |
Secondary
| Measure | Time frame |
|---|---|
| a.Mortality assessment b.Evaluation of Glasgow Outcome Scalec. c.Evaluation of Extended Glasgow outcome score (GOS-E) d.Quality of Life using Short Form (36) Health Survey (SF-36) e.Changes in Intracranial Pressure (ICP) and Cerebral Perfusion Pressure (CPP) f.Changes in intracranial pathology as assessed by admission and Day 6 computed tomography (CT) scans g.Changes in biochemical markers of severe traumatic brain injury .Timepoint: a.At 1 month and 6 months post injury b.At 3 months c.At 3 and 6 months d.At 3 and 6 months g.At 120 hours after the administration of the drug/ placebo | — |
Countries
India
Contacts
Public ContactSumit Sinha
JPNA Trauma Center, All Institute of Medical Science
Outcome results
None listed