Platelet Bioenergetics in TBI

NCT04271059 | Terminated

• 1 other identifier: 54012
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injuries, Traumatic

Keywords

TBI

Outcome Measures

Primary Outcomes (1)

• Change in Platelet Bioenergetics

  Change in various platelet oxygen consumption rates and extracellular acidification rate

  0-72 hours

Secondary Outcomes (1)

• Identify platelet bioenergetic rate of healthy adults.

  24 hour.

Study Arms (3)

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.

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.

Healthy Control

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Up to fifteen (15) subjects, who are between the ages of 18-50, including both males and females, from all ethnic and racial backgrounds will be included in this study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kevin Hatton: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• kevin Hatton, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: February 13, 2020
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)