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Completed

NCT Number: NCT01143064

Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury

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.

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Francisco Lopez Lima, General Roca, Río Negro Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

Progesterone

Drug

Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

Other names: BHR-100

Lipid emulsion without progesterone

Drug

Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

Primary outcomes

  1. Glasgow Outcome Scale (GOS)

    Time frame: 6 months

    The GOS assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.

Secondary outcomes

  1. Mortality at Month 1

    Time frame: 1 month post injury

    The mortality rate at one month will be compared between the two treatment groups.

  2. Mortality at Month 6

    Time frame: 6 months post injury

    The mortality rate at six months will be compared between the two treatment groups.

  3. Glasgow Outcome Scale at 3 Months

    Time frame: Month 3

    The GOS assesses the mortality and disability in traumatic brain injury patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State, or Dead.

  4. Glasgow Outcome Scale - Extended (GOS-E)

    Time frame: 3 months and 6 months post injury

    The GOS-E assessment of mortality and disability in TBI patients extends the original five GOS categories of functional outcome to eight categories:

    • Dead
    • Vegetative State
    • Lower Severe Disability
    • Upper Severe Disability
    • Lower Moderate Disability
    • Upper Moderate Disability
    • Lower Good Recovery
    • Upper Good Recovery

  5. Short Form (36) Health Survey (SF-36)

    Time frame: 3 months and 6 months post injury

    The Short Form (36) Health Survey (SF-36) is a validated survey of patient health consisting of eight scaled scores which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, role physical, role emotional, role mental and mental health. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The 8 scales can also be further summarized to provide a summary score for physical health and a summary score for mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  6. Potentially Clinically Important On-Treatment Cerebral Perfusion Pressure (CPP) and Summary of Maximum Therapy Therapeutic Intensity Level (TIL)

    Time frame: Admission through post-infusion Day 6

    Cerebral Perfusion Pressure (CPP) levels are presented according to clinically significant cut-off values. CPP was calculated from intracranial pressures and mean arterial pressures measured from Day through Day 6 after initiation of study medication, if an ICP monitor was in place. Specific therapies received during Days 1-6 are summarized according to the Therapeutic Intensity Level (TIL) by treatment group, as maximum level of therapy administered to the subject.

Sponsors and collaborators

Lead sponsor

BHR Pharma, LLC

Industry

Collaborators

  • PRA Health Sciences
  • Syneos Health

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients With Severe Traumatic Brain Injury

Acronym: SyNAPSe

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 14, 2010
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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