Methods for aiding in diagnosing and evaluating a mild traumatic brain injury in a human subject using cardiac troponin I

A method comprising:

• a) 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;
• and
• b) 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;
• and wherein the subject levels of cTnI are distinct from levels of cTnI in a control subject that has no traumatic brain injury;
• and
• (c) treating the subject for
• (1) a moderate, severe, or moderate to severe TBI when the level of cTnI in the sample is higher than a reference level of cTnI (a) with one or more therapeutic agents;
• (b) with one or more surgical procedures;
• (c) by protecting the subject's airway;
• (d) with one or more therapies selected from the group consisting of rehabilitation, physical therapy, occupational therapy, cognitive behavioral therapy, anger management, counseling and any combinations thereof;
• or (e) with any combination of (a)-(d);
• or
• (2) a mild TBI when the level of cTnI in the sample is lower than a reference level of cTnI (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;
• or (f) with any combination of (a′)-(e′).

A method comprising:

• a) 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;
• and
• b) 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;
• and
• 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, and
• further wherein the subject levels of cTnI are distinct from levels of cTnI in a control subject that has no TBI.

The method of 12, wherein:

• (a) the first sample is taken from the subject within about 30 minutes, within about 1 hour, within about 2 hours, within about 3 hours, within about 4 hours, within about 5 hours, within about 6 hours, within about 7 hours, within about 8 hours, within about 9 hours, within about 10 hours, within about 11 hours, within about 12 hours, within about 13 hours, within about 14 hours, within about 15 hours, within about 16 hours, within about 17 hours, within about 18 hours, within about 19 hours, within about 20 hours, within about 21 hours, within about 22 hours, within about 23 hours, or within about 24 hours of the actual or suspected injury to the head;
• (b) the assay is selected from the group consisting of an immunoassay, a clinical chemistry assay, and a point-of-care assay and/or the assay is performed using single molecule detection;
• or
• (c) a subject with (1) a moderate, severe, or moderate to severe TBI is treated (a) with one or more therapeutic agents;
• (b) with one or more surgical procedures;
• (c) by protecting the subject's airway;
• (d) with one or more therapies selected from the group consisting of rehabilitation, physical therapy, occupational therapy, cognitive behavioral therapy, anger management, counseling and any combinations thereof;
• or (e) with any combination of (a)-(d);
• or (2) a mild TBI is treated (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;
• or (f) with any combination of (a′)-(e′).

A method comprising:

• a) 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;
• and
• b) 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;
• and
• 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 1 to about 4 hours, and further wherein the subject levels of cTnI are distinct from levels of cTnI in a control subject that has no TBI.

The method of 15, wherein:

• (a) the first sample is taken from the subject within about 30 minutes, within about 1 hour, within about 2 hours, within about 3 hours, within about 4 hours, within about 5 hours, within about 6 hours, within about 7 hours, within about 8 hours, within about 9 hours, within about 10 hours, within about 11 hours, within about 12 hours, within about 13 hours, within about 14 hours, within about 15 hours, within about 16 hours, within about 17 hours, within about 18 hours, within about 19 hours, within about 20 hours, within about 21 hours, within about 22 hours, within about 23 hours, or within about 24 hours of the actual or suspected injury to the head;
• (b) the assay is selected from the group consisting of an immunoassay, a clinical chemistry assay, and a point-of-care assay and/or the assay is performed using single molecule detection;
• (c) the amount of cTnI in the first sample or second sample is from about 1.0 to about 50 pg/mL;
• or
• (d) a subject with (1) a moderate, severe, or moderate to severe TBI is treated (a) with one or more therapeutic agents;
• (b) with one or more surgical procedures;
• (c) by protecting the subject's airway;
• (d) with one or more therapies selected from the group consisting of rehabilitation, physical therapy, occupational therapy, cognitive behavioral therapy, anger management, counseling and any combinations thereof;
• or (e) with any combination of (a)-(d);
• or (2) a mild TBI is treated (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;
• or (f) with any combination of (a′)-(e′).

A method comprising:

• a) 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;
• and
• b) 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 by at least about 20% 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 24 hours after the actual or suspected head injury and the second time point is within about 0 to about 4 hours, and further wherein the subject levels of cTnI are distinct from levels of cTnI in a control subject that has no TBI.