Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury

Launched by UNIVERSITY OF ARIZONA · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a drug called Angiotensin (1-7) to see if it is safe and effective for individuals who have experienced a moderate to severe traumatic brain injury (TBI). The main goals are to determine if the drug can help improve mental functioning and reduce visible signs of brain damage after such an injury. Participants in the study will receive daily injections of the drug for 21 days, provide blood samples, undergo two brain scans (MRIs), and complete various tasks and questionnaires to assess their brain and mental health.

To be eligible for this trial, participants need to be at least 18 years old and have suffered a traumatic head injury that caused significant damage, as identified by a medical imaging report. They must be enrolled in the study within 48 hours of their injury. It’s important to note that individuals with certain medical conditions or who have had recent surgeries may not be able to participate. Overall, this study aims to gather important information that could lead to better treatments for people recovering from serious brain injuries.

Gender

ALL

Eligibility criteria

• 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.