Status:
COMPLETED
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
Lead Sponsor:
BHR Pharma, LLC
Collaborating Sponsors:
PRA Health Sciences
Syneos Health
Conditions:
Brain Injuries
Eligibility:
All Genders
16-70 years
Phase:
PHASE3
Brief Summary
The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
1195 Patients enrolled
Trial Details
Trial ID
NCT01143064
Start Date
June 1 2010
End Date
March 1 2014
Last Update
October 2 2024
Active Locations (156)
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1
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
2
LAC+USC Medical Center
Los Angeles, California, United States, 90033
3
University of California San Diego Medical Center
San Diego, California, United States, 92103
4
Denver Health Medical Center
Denver, Colorado, United States, 80204