Methods for aiding in diagnosing and evaluating a mild traumatic brain injury in a human subject using cardiac troponin I
Inventors
McQuiston, Beth • Korley, Frederick • Beshiri, Agim • Marino, Jaime • Datwyler, Saul
Assignees
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Publication Number
US-12178592-B2
Publication Date
2024-12-31
Expiration Date
Abstract
Disclosed herein are methods that aid in the diagnosis and evaluation of a human subject that has sustained or may have sustained an injury to the head, such as mild or moderate, severe, or moderate to severe traumatic brain injury (TBI), using cTnI. Also disclosed are methods for determining whether to perform a head computerized tomography on a subject by detecting levels of cTnI. Finally, also disclosed are methods of outcome in subjects suffering from a mild TBI.
Core Innovation
The invention provides methods that perform at least one assay for cardiac troponin I (cTnI) in at least one sample that is whole blood, serum, plasma, or cerebrospinal fluid obtained from a subject within about 24 hours after an actual or suspected injury to the head. The level of cTnI in the sample is compared to a reference level of cTnI, and the subject cTnI levels are distinct from levels of cTnI in a control subject that has no TBI.
Based on whether the level of cTnI is higher than or lower than a reference level, the method directs treatment classification for mild traumatic brain injury (TBI) versus moderate, severe, or moderate to severe TBI. In additional embodiments, the method includes performing a head computed tomography (CT) scan when the cTnI level is higher than the reference level, and serial determination of cTnI at first and second time points after injury, with treatment applied when cTnI increases between the samples.
Reference levels can be defined or constrained using assay performance metrics, including sensitivity and specificity, and by cTnI concentration ranges, including explicit reference cTnI values. Treatment options include one or more therapeutic agents, one or more surgical procedures, protecting the subject's airway, rehabilitation, physical therapy, occupational therapy, cognitive behavioral therapy, anger management, counseling, rest, abstaining from physical activities, avoiding light, and wearing protective eyewear when in light.
Claims Coverage
The independent claims center on performing cTnI assays on specified sample types within defined post-injury windows, comparing cTnI to a reference level to classify TBI severity for treatment, adding a head CT scan branch when cTnI is higher than the reference level, and using serial sampling to apply treatment based on cTnI increase between time points.
Ctni assay within about 24 hours and treatment by above vs below reference level
Performing at least one assay for cardiac troponin I (cTnI) in at least one sample that is whole blood, serum, plasma, or cerebrospinal fluid obtained from a subject within about 24 hours after an actual or suspected injury to the head; treating the subject for moderate, severe, or moderate to severe TBI when the level of cTnI in the sample is higher than a reference level of cTnI, or treating for mild TBI when the level of cTnI in the sample is lower than a reference level of cTnI; wherein the subject levels of cTnI are distinct from levels of cTnI in a control subject that has no TBI.
Head CT scan when cTnI is higher than reference level and branch-specific treatment
Performing at least one assay for cardiac troponin I (cTnI) in at least one sample that is whole blood, serum, plasma, or cerebrospinal fluid obtained from a subject within about 24 hours after an actual or suspected injury to the head; performing a head computed tomography (CT) scan on the subject when the level of cTnI in the sample is higher than a reference level of cTnI; treating the subject for moderate, severe, or moderate to severe TBI when the level of cTnI in the sample is higher than a reference level of cTnI with one or more therapeutic agents, one or more surgical procedures, protecting the subject's airway, rehabilitation, physical therapy, occupational therapy, cognitive behavioral therapy, anger management, counseling, or any combinations thereof; or treating for mild TBI when the level of cTnI in the sample is lower than a reference level of cTnI with rest, abstaining from physical activities, avoiding light, wearing protective eyewear when in light, one or more therapeutic agents, or any combination thereof.
Serial cTnI assays with treatment when cTnI increases
Performing at least one assay for cardiac troponin I (cTnI) in at least a first sample taken at a first time point and a second sample taken at a second time point and obtained from a human subject after an actual or suspected injury to the head; treating the subject for mild, a moderate, severe, or moderate to severe traumatic brain injury (TBI) when the level of cTnI in the sample has increased from the first sample to the second sample; wherein the sample is whole blood, serum, plasma, or cerebrospinal fluid obtained; wherein the first time point is within about 24 hours after the actual or suspected head injury and the second time point is within about 3 to about 6 hours; further wherein the subject levels of cTnI are distinct from levels of cTnI in a control subject that has no TBI.
Overall, claim coverage centers on cTnI-based reference-level comparisons to classify mild versus moderate-to-severe TBI for treatment, adding a head CT scan branch when cTnI is higher than the reference level and differing treatment options for elevated versus reduced cTnI, and using serial cTnI sampling with treatment triggered by an increase between specified time points while distinguishing from control subjects without TBI.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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