US 12,085,567 B2
Methods for aiding in the hyperacute diagnosis and determination of traumatic brain injury using early biomarkers on at least two samples from the same human subject
Beth McQuiston, Abbott Park, IL (US); Justin Rogers, Abbott Park, IL (US); Saul Datwyler, Abbott Park, IL (US); and Jaime Marino, Abbott Park, IL (US)
Assigned to ABBOTT LABORATORIES, Abbott Park, IL (US)
Filed by Abbott Laboratories, Abbott Park, IL (US)
Filed on Nov. 11, 2020, as Appl. No. 17/095,695.
Application 17/095,695 is a continuation of application No. 15/963,627, filed on Apr. 26, 2018, granted, now 10,877,038.
Claims priority of provisional application 62/491,600, filed on Apr. 28, 2017.
Prior Publication US 2021/0072243 A1, Mar. 11, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/573 (2006.01); A61B 6/03 (2006.01); A61B 6/50 (2024.01); G01N 33/68 (2006.01)
CPC G01N 33/573 (2013.01) [A61B 6/032 (2013.01); A61B 6/501 (2013.01); G01N 33/6896 (2013.01); G01N 2333/46 (2013.01); G01N 2333/916 (2013.01); G01N 2333/948 (2013.01); G01N 2800/28 (2013.01)] 18 Claims
 
1. A method comprising:
a) performing at least one assay for ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), or a combination thereof 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; and
b) treating the subject for:
i. a moderate, severe, or moderate to severe traumatic brain injury (TBI) when the level of UCH-L1 increases or decreases by at least about 40 pg/mL from the first sample to the second sample, or a mild TBI when the level of UCH-L1 does not increase or decrease by at least about 40 pg/mL from the first sample to the second sample;
it. a moderate, severe, or moderate to severe TBI when the level of GFAP increases or decreases by at least about 1 pg/mL from the first sample to the second sample, or a mild TBI when the level of GFAP does not increase or decrease by at least about 1 pg/mL from the first sample to the second sample; or
iii. a moderate, severe, or moderate to severe TBI when the level of UCH-L1 increases or decreases by at least about 40 pg/mL from the first sample to the second sample and the level of GFAP increases or decreases by at least about 1 pg/mL from the first sample to the second sample or a mild TBI when the level of UCH-L1 does not increase or decrease by at least about 40 pg/mL from the first sample to the second sample and the level of GFAP does not increase or decrease by at least about 1 pg/mL from the first sample to the second sample; and
wherein the sample is whole blood, serum, plasma, or cerebrospinal fluid;
wherein the first time point is within about 2 hours after the actual or suspected head injury and the second time point is within about 3 to about 6 hours after the first sample is taken and
wherein treatment for a moderate, severe, or moderate to severe TBI comprises: treatment (a) with one or more therapeutic agents selected from the group consisting of a diuretic, an anti-convulsant medication and a medication to sedate an individual or induce a coma, or any combination thereof; (b) with one or more surgical procedures selected from the group consisting of removal of a hematoma, repairing a skull fracture, and a decompressive craniectomy, or any combinations thereof; (c) with one or more therapies selected from the group consisting of rehabilitation for TBI, cognitive behavioral therapy, anger management, counseling psychology and any combinations thereof; or (d) with any combination of (a)-(c); or
wherein treatment for a mild TBI comprises: treatment (a′) with rest; (b′) by abstaining from physical activities; (c′) by avoiding light (d′) by wearing protective eyewear when in light; (e′) with one or more therapeutic agents selected from the group consisting of a medication for relief of headache or migraine, and an anti-nausea medication or combinations thereof; or (f) with any combination of (a′)-(e′).