Clinical trial NCT04271059: Platelet Bioenergetics in TBI
Official title: The Effect of Platelet Bioenergetics in Traumatic Brain Injuries
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Injuries, Traumatic
Keywords: TBI
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Platelet Bioenergetics
timeFrame: 0-72 hours
Secondary outcomes:
measure: Identify platelet bioenergetic rate of healthy adults.
timeFrame: 24 hour.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: kevin Hatton, MD
role: PRINCIPAL_INVESTIGATOR
References: