a clinical trial of progesterone with or without hypothermia in patients with severe head injury
Phase 2
- Conditions
- Health Condition 1: null- Severe Traumatic Brain Injury
- Registration Number
- CTRI/2009/091/000893
- Lead Sponsor
- DEPARTMENT OF BIOTECHNOLOGY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria
i.Male or female patients between the ages of 18 and 65 years with suspected TBI
ii.Glasgow Coma Scale (GCS) score 4-8 after resuscitation and stabilization
iii.Patients who arrived within 8 hrs of injury
Exclusion Criteria
i.Patients who had received any investigational drugs 30 days prior to the enrollment, such as progesterone, estrogen and any other investigational compound
ii.Patients with severe anoxic intracerebral damage or brain death
iii.Patients whose clinical condition is unstable (partial pressure of oxygen 60 mmHg or a systolic blood pressure 90 mmHg, or both)
iv.Pregnant or lactating female patients
v.Doubt whether the altered neurological status resulted from head trauma or acute or chronic spinal cord injury.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Glasgow Outcome Scale (GOS) score <br/ ><br>Timepoint: at 1 month, <br/ ><br>at 3 months and <br/ ><br>at 6 months
- Secondary Outcome Measures
Name Time Method 1. Functional Independence Measure (FIM) score <br/ ><br>2. mortalityTimepoint: at 1 month, <br/ ><br>at 3 months and <br/ ><br>at 6 months