Testing Angiotensin (1-7) for treating moderate to severe traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of Angiotensin (1-7) in individuals who have experienced moderate to severe traumatic brain injury (TBI). Participants will receive daily injections of the drug for 21 days, undergo MRI scans, and complete cognitive assessments to measure improvements in mental functioning and physical signs of brain damage. The study will compare two different doses of Angiotensin (1-7) against a placebo to determine its effectiveness and safety profile.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant or representative willing to provide informed consent.
* Age 18 years or older at time of enrollment.
* Traumatically induced head injury resulting from insult to head from an external force.
* Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CT scan and report must be available.
* Moderate or severe traumatic brain injury (TBI) defined as Glasgow Coma Scale (GCS) score on trauma presentation of 12 or less. In general: Moderate TBI will be defined as loss of consciousness between 30 minutes and 24 hours and GCS between 9 and 12. Severe TBI will be defined as loss of consciousness \> 24 hours and GCS ≤ 9.
* Enrollment within 48 hours of TBI.

Exclusion Criteria:

* Time of injury cannot be determined.
* Neurosurgery within the last 30 days.
* History of neurodegenerative disease or disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors that would impact cognitive testing.
* Contraindication to having an MRI.
* Pregnant or lactating female.
* Female of childbearing potential or sexually active male who is not willing to use an acceptable method of birth control for the treatment period and 7 days after the last dose of the study drug.
* Participation in another clinical study involving investigational product within 30 days prior to study enrollment.
* If in the opinion of the investigator, candidate is unsuitable for participation in the study.

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting

Study contacts

• Principal investigator: Magnotti Louis, MD — University of Arizona
• Study coordinator: Clinical Research Coordinator
• Email: traumaresearch@arizona.edu
• Phone: (520) 237-6845

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.