Analytical characterization and validation of blood-biomarkers for monitoring TBI evolution

Active Cooperative Agreement Awarded Last action

Award ID
U01NS131740
Recipient
Awarding agency
Obligated
$6,028,046

Award facts

Completion date 56% complete
Place of performance
Pittsburgh, PA 15213, USA

Award details come from USAspending.gov.

Description

Abstract
Consistent with the overall mission of ninds for the PAR-21-056 announcement, analytical validation of a candidate biomarker for neurological disease, we have assembled a team of investigators from the international initiative on traumatic brain injury research (intbir) to conduct analytical validation of 7 emerging TBI biomarkers: UCH-L1, gfap, NFL, TAU, brain derived (BD) TAU, ptau-181 and ptau-231. The absolute values reported for any particular analyte, measured on different platforms, often differ substantially, making IT difficult to interpret findings across studies and limiting their eventual clinical adoption. To achieve clinical acceptance, assessment of pre-analytical variables, namely how small variations of sample collection protocols and analytical methods influence the results, is essential for establishing standard operating procedures. Universal cut-offs and population-based reference intervals (RI) also will assist in interpretation of biomarker results. Such efforts in the pre-competitive space will substantially ease the transition from research-use-only into clinical practice. This will be the first study to investigate the role of neurotrauma biomarkers as monitoring biomarkers of the temporal evolution of TBI in two common clinical contexts of use (COU). We will assay existing blood samples collected in > 80 hospitals worldwide as part of the USA track-TBI study, the european center-TBI study, and the canadian cantbi study, for the 7 biomarkers selected for this project. The first COU focuses on patients evaluated in the ED and discharged to their home. We will investigate the risk stratification/prognostic value of these TBI biomarkers to detect or predict the occurrence of persistent post-concussion syndrome. The second COU focuses on patients admitted to the intensive care unit with severe TBI. We will investigate the relationship and effect size of secondary biomarker elevations with TBI complications such as intracranial hypertension, as a neuromonitoring role. These pre-competitive space studies are important for the development of these biomarkers in the TBI arena, as well as the near future use and adoption in the acute clinical setting.

Transactions

Action Obligated Date
Amendment $1,618,468
Amendment $1,520,962
Amendment $0
Amendment $0
Amendment $0
Amendment $1,444,308
Original award $1,444,308

Subawards

Subrecipient Amount Awarded
Foundation For Applied Molecular Evolution, Inc. This subaward will provide antigen procurement and qualification and analytical validation. $242,005
The Trustees Of The University Of Pennsylvania Analytical characterization and validation of blood-biomarkers for monitoring TBI evolution $351,832
The Morehouse School Of Medicine, Inc. 720 Westview Drive Atlanta, GA 303100000 $214,305
The University Of British Columbia Analytical characterization and validation of blood-biomarkers for monitoring TBI evolution $127,472
The Hospital For Sick Children $121,811

Quick answers

Who received award U01NS131740?

U01NS131740 was awarded to University Of Pittsburgh - Of The Commonwealth System Of Higher Education by National Institute of Neurological Disorders and Stroke (National Institutes of Health) on August 10, 2024.

How much is award U01NS131740 worth?

$6,028,046 has been obligated on U01NS131740.

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