Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury (RAPID-TBI)
Overview
This study will look to validate predictive algorithms developed in a previous study where we collected relevant data from trauma registry and after using advanced signal-processing and machine-learning, determined prediction scores regarding neuroworsening and other outcomes following traumatic brain injury.
Primary outcome measures
- Neurological Decline [Time frame: First 48 hours of injury]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Maryland Medical Center — Baltimore
Identifiers
NCT: NCT05084352 · HP-00087051