NCT05848297 Automated Robotic TCD in Traumatic Brain Injury
| NCT ID | NCT05848297 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Commonwealth University |
| Condition | Brain Injuries, Traumatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-05-20 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study's objective is to determine the safety, feasibility and efficacy of prolonged automated robotic TCD monitoring in critically ill patients with severe TBI across multiple clinical sites with varying levels of TCD availability and experience
Eligibility Criteria
Inclusion Criteria: * Adults ≥18 * Blunt TBI with Glasgow Coma Score (GCS) ≤8 * Injury within 72 hours * Adequate TCD windows * Ability to obtain informed consent from a Legally Authorized Representative (LAR) Exclusion Criteria: * Catastrophic brain injury with grim prognosis (e.g.: GCS 3 with bilateral mid-position pupil) * C- spine fracture with evidence of spinal cord injury * Severe skull or scalp injury precluding device placement * Planned decompressive hemicraniectomy * Continuous fever for \>6 hours at the time of enrollment (despite treatment) * Lack of TCD window
Contact & Investigator
Shraddha Mainali
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT05848297 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Injuries, Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05848297 currently recruiting?
Yes, NCT05848297 is actively recruiting participants. Contact the research team at shraddha.mainali@vcuhealth.org for enrollment information.
Where is the NCT05848297 trial being conducted?
This trial is being conducted at Davis, United States, Winston-Salem, United States, Richmond, United States.
Who is sponsoring the NCT05848297 clinical trial?
NCT05848297 is sponsored by Virginia Commonwealth University. The principal investigator is Shraddha Mainali at Virginia Commonwealth University. The trial plans to enroll 30 participants.