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

A technology for subjects and brain injury, applied in the fields of biochemical equipment and methods, diagnosis, disease diagnosis, etc., can solve problems such as unresearched relationship between cardiac injury and neurological outcomes, spectral bias in findings, and unresearched cardiac injury effects.

Pending Publication Date: 2020-01-17
ABBOTT LAB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because these findings are retrospective and troponin measurements are performed at the clinician's discretion (which they rarely do in routine care of TBI patients), these findings are subject to spectral bias
Furthermore, the relationship between cardiac injury and neurological outcomes in TBI has not been studied
In addition, the role of cardiac injury in mild and moderate TBI has not been studied

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0551] Study 1 - TBI Population

[0552] Study 1 is a large and complex project. Its institutional and public-private partnerships include more than 11 clinical sites, seven cores, and a total of nearly 50 partner institutions, companies and charities. An earlier pilot study, based on clinical data from three clinical sites, helped refine the TBI common data element and create a prototype of the TBI information commons space used in Study 1.

[0553] Subject Groups: A total of 2,700 to 3,000 TBI patients were equally enrolled by clinical care pathways into 3 clinical groups: 1. Patients who were evaluated in the emergency department and discharged (ED); 2. Patients who were admitted but not admitted to the ICU Patient (ADM); and 3. Patient admitted to ICU (ICU). Each clinical group additionally enrolled 100 (n=300) patients with extracranial trauma but no TBI as controls, and a total of 3000 patients were enrolled. This stratification scheme facilitates Comparative Effects ...

Embodiment 2

[0587] Study 2 - Development of a Multimodal Classification Scheme for Traumatic Brain Injury.

[0588] The goal of this study was to develop a brain injury classification scheme that indicates the nature (type) and severity of the injury. For example, serum biomarkers reveal cell types. Trauma patients were analyzed in three groups: brain injury only, non-brain injury only, and combined injury. Trauma groups with brain injury and non-brain injury were compared with each other and with combined brain / non-brain injury. These trauma groups were compared to a non-trauma control group. CSF of trauma patients was compared with CSF of non-trauma patients. A secondary objective was to determine whether any of the described measures, alone or in combination, had utility as predictors of clinical outcomes after TBI.

[0589] An objective multimodal classification scheme and outcome measure for traumatic brain injury was developed based on several measures: 1) blood-based biomarkers...

Embodiment 3

[0617] Study 2 - Analysis

[0618] As described in Example 5, high sensitivity troponin I (hsTnI) was measured in samples obtained from subjects using the Abbott Architect STAT hsTnI assay. Figure 6 and Figure 7 showed, based on CT scan results ( Figure 6 ) and GCS score ( Figure 7 ), hsTnI levels correlate with injury throughout the first 24 hours post-injury (range approximately 2-23 hours).

[0619] Samples taken from subjects within 2 hours of injury: hsTnl levels are measured in samples taken from human subjects within approximately 2 hours of suspected injury. Figure 8 ROC analysis (AUC=0.430) of the correlation of hsTnl levels with CT status (positive vs. negative CT scan results) is shown. Table 12 shows the sensitivity and specificity of using hsTnI cut-off levels to predict positive CT scan results.

[0620] Table 12 CT scan – hsTnI reference level analysis

[0621]

[0622] Figure 9 ROC analysis (AUC=0.588) of association of hsTnI with GCS score outc...

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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, alsodisclosed are methods of outcome in subjects suffering from a mild TBI.

Description

[0001] Related application information [0002] This application claims U.S. Application No. 62 / 512,688, filed May 30, 2017, U.S. Application No. 62 / 512,710, filed May 30, 2017, and U.S. Application No. 62 / 5, filed July 3, 2017 528,214, the contents of each of which are incorporated herein by reference. technical field [0003] The present disclosure relates to methods of aiding diagnosis and assessment in human subjects who have suffered or may have suffered (or have actual or suspected) head injury, such as mild traumatic brain injury (TBI), by The level of cardiac troponin I (cTnI) is detected in samples (or biological samples) obtained from the human subjects at the injury time point after the subject suffers or may suffer (or has actual or suspected) head injury. The present disclosure also provides methods of determining whether to perform head computed tomography on a subject based on detecting various cTnI levels. The present disclosure also provides methods of predi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N2800/28G01N2800/56G01N33/6896A61B5/4064C12Q1/6883G01N33/533G01N33/54366G01N33/564G01N33/54346G01N33/577G01N33/6893G01N2800/52G01N2800/60
Inventor B·麦奎斯顿F·科利A·贝希里J·马力诺S·德特维勒
Owner ABBOTT LAB INC
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