Patient Care,

Clinical Hub,References,Emergency Department Resources

BHR 100-301 Closed Head Trauma Study

BHR 100-301 Closed Head Trauma Study - Clinical Hub, References, Emergency Department Resources


Eligibility Requirements for BHR Head Trauma Study

BHR (Synapse) Progesterone/Closed Head Trauma Study- P.I. Josh Medow

Inclusion Criteria:

  1. Male or female patients, age between 16 and 70 years, inclusive (or the 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:

  1. Life expectancy of less than 24 hours as determined by the Investigator
  2. Prolonged and/or uncorrectable hypoxia (Pa02)
  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. 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 (e.g. eggs and soy)
  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)

Mobile Research Team Pager: 7126


MD Info Sheet for BHR 100-301 Traumatic Brain Injury Study