Platelet Bioenergetics in TBI

Terminated

• Conditions: Brain Injuries, Traumatic

• Registration Number: NCT04271059
• Lead Sponsor: Kevin Hatton

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Study Start: 2020-02-13
• Primary Completion: 2020-02-13
• Study Completion: 2020-02-13
• Study First Posted: 2020-02-17
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Platelet Bioenergetics	0-72 hours	Change in various platelet oxygen consumption rates and extracellular acidification rate

Secondary Outcome Measures

Name	Time	Method
Identify platelet bioenergetic rate of healthy adults.	24 hour.	Identify normal platelet oxygen consumption rates and extracellular acidification rate based on patient demographics.

Trial Locations

Locations (1)

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States