Platelet Bioenergetics in TBI

Kevin Hatton

Status: Terminated

Conditions: Brain Injuries, Traumatic

Study type: Observational

Funder types: Other

Identifiers

NCT04271059

54012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1 participants in 3 patient groups

TBI without polytrauma

Description:

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

Description:

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

Description:

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