Longitudinal Assessment of Traumatic Microvascular Injury-2

University of Pennsylvania1 site in 1 country110 target enrollmentFebruary 1, 2022

ConditionsTraumatic Brain Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Traumatic Brain Injury
Sponsor: University of Pennsylvania
Enrollment: 110
Locations: 1
Primary Endpoint: Brain Atrophy
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this observational study is to learn about changes in the brain of patients over the first 3 years following a traumatic brain injury (TBI). The main question it aims to answer are:

How TBI effect the rate of brain tissue loss compare to healthy brain

Participants will give blood samples, complete MRI scans, and neuropsychological assessment measures.

Researchers will compare results between healthy control group and TBI group to determine changes in injured brains.

Registry

clinicaltrials.gov

Start Date

February 1, 2022

End Date

March 1, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-65, inclusive
•History of non-penetrating TBI of at least moderate severity (defined by evidence of trauma-related neuroimaging abnormality on cranial computerized tomography (CT) scan.
•High-velocity, high-impact injury mechanism consistent with diffuse axonal injury (e.g., motor vehicle accident, fall from height, etc.)
•Immediate loss of consciousness (cases with delayed loss of consciousness due to expanding lesions will be excluded)

Exclusion Criteria

•History of premorbid disabling neurological or psychiatric disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, HIV-encephalitis)
•History of premorbid disability condition that would interfere with outcome assessments
•Bilaterally absent pupillary Reponses
•Penetrating TBI
•Elevated intracranial pressure (≥ 17 mmHg) 6 Contradictions to contrast-enhanced MRI (e.g., ferromagnetic implants, pregnancy, allergy to gadolinium contrast, renal impairment \[GFR \< 60ml/g/m3\], claustrophobia, hemodynamic instability)
•Prisoners, patients in police custody
•Objective lung disease (PaCO2 at rest \> 50 mmHg or venous serum bicarbonate \> 26 mEg/L) based on any labs available for review from patient's clinical care. Note that these will not be checked solely for study purposes 9.Requiring portable oxygen at enrollment
•Chronic heart failure, severe pulmonary disease
•Current substance abuse that precludes participation and follow-up in the study, as determined by the study investigators
•If there is medical or other disability that precludes completion of the study procedures as determined by the study investigators