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Platelet Bioenergetics in TBI

NCT ID: NCT04271059

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-13

Study Completion Date

2020-02-13

Brief Summary

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This is a prospective study enrolling 5 patients with a diagnosis of traumatic brain injury (TBI) without polytrauma and 5 patients with TBI with polytrauma admitted to the University of Kentucky (UK) Chandler Medical Center to evaluate differences in platelet bioenergetics in the populations. Additionally, five healthy subjects will be recruited to the control group.

Detailed Description

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Traumatic brain injury (TBI) is used to describe a myriad of primary and secondary brain-related injuries related to trauma. Clinically, moderate-to-severe brain injury results in early coagulopathy, with a tendency toward unanticipated bleeding, followed by delayed hypercoagulation, with a tendency toward unanticipated clot formation. Optimal platelet count, activation and function are necessary for normal coagulation. Investigators have recently developed a novel approach to measure platelet activity. This approach specifically measures platelet energy output or bioenergetics from blood samples. Preclinical (animal) studies show that platelet bioenergetic profiles are different after TBI and that they change over time. This temporal profile may be used as a biomarker that can inform diagnosis and prognosis of TBI.

Conditions

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Brain Injuries, Traumatic

Keywords

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TBI

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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TBI without polytrauma

Subjects who have experienced a severe traumatic brain injury (Glasgow Coma Scale (GCS) 3-13) within the last 12 hours, without additional polytrauma.

No interventions assigned to this group

TBI with polytrauma

Subjects who have experienced a severe traumatic brain injury (Glasgow Coma Scale (GCS) 3-13) and polytrauma, including major trauma to the chest, abdomen, pelvis or extremities. within the last 12 hours.

No interventions assigned to this group

Healthy Control

Subjects who have not experienced any TBIs within the last six months.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients must have moderate to severe traumatic brain injury (Glasgow Coma Scale (GCS) 3-13) to be enrolled in the TBI or TBI with trauma groups.
* Patients enrolled in the TBI with polytrauma group must also exhibit polytrauma including concomitant traumatic brain injury, major trauma to the chest, abdomen, pelvis or extremities.
* Patients must be greater than or equal to 18 years of age and must be less than or equal to 50 years of age.
* Patients must be able to cooperate for a detailed neurologic exam.
* Patients must be consented and undergo first blood sampling within the first 12 hours (+/- 2 hours) after their traumatic brain injury to be enrolled in the TBI or TBI with trauma groups.
* Patients must be expected to survive to discharge, as assessed by their admitting neurosurgery team

Exclusion Criteria

* For the control group only, patients who have experienced a TBI in the last 6 months.
* Diagnosis of platelet diseases or disorders, such as thrombocytopenia, thrombocytosis, or Von Willebrand disease.
* Platelet transfusion within the last six months.
* Comorbid regimen of Metformin within the last 6 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kevin Hatton

OTHER

Sponsor Role lead

Responsible Party

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Kevin Hatton

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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kevin Hatton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky Medical Center

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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54012

Identifier Type: -

Identifier Source: org_study_id