Assessing vital signs to predict neurological decline after brain injury
Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury (RAPID-TBI)
This study is testing if certain vital signs can help predict if people with a brain injury will get worse after they arrive at the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05084352 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate predictive algorithms that were developed to assess the risk of neurological decline following traumatic brain injury (TBI). By collecting relevant data from a trauma registry and applying advanced signal-processing and machine-learning techniques, the study seeks to generate prediction scores for neuroworsening and other outcomes. Patients who arrive at the hospital within six hours of injury and meet specific inclusion criteria will be monitored to gather data for analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 89 who have sustained a traumatic brain injury and arrive at the hospital within six hours of the incident.
Not a fit: Patients with non-survivable TBIs, those who are brain dead on arrival, or individuals with active substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of neurological outcomes in TBI patients, allowing for timely interventions.
How similar studies have performed: Other studies utilizing predictive algorithms for neurological outcomes in TBI have shown promise, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Arrival to the hospital within 6 hours of injury * Age \>= 18 years old * Patients with traumatic brain injury(TBI). TBI is defined as any alteration or loss of consciousness with or without positive head C.T findings. Exclusion Criteria: * Deemed to have a non-survivable TBI * Brain dead on arrival * Active substance abuse for opiates and cocaine as noted by admission toxicology screen. * Any thoracic or abdominal injury resulting in open surgical intervention * Pregnancy * Prisoners * Active military * Non - English speaking (due to necessity for consent in aims 2 and 3) * Age \> 89 years
Where this trial is running
Baltimore, Maryland
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Neeraj Badjatia, MD MSc
- Email: nbadjatia@umm.edu
- Phone: 14103284515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.