- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04271059
Platelet Bioenergetics in TBI
October 20, 2021 updated by: Kevin Hatton
The Effect of Platelet Bioenergetics in Traumatic Brain Injuries
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.
Study Overview
Status
Terminated
Conditions
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 Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Platelet Bioenergetics
Time Frame: 0-72 hours
|
Change in various platelet oxygen consumption rates and extracellular acidification rate
|
0-72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identify platelet bioenergetic rate of healthy adults.
Time Frame: 24 hour.
|
Identify normal platelet oxygen consumption rates and extracellular acidification rate based on patient demographics.
|
24 hour.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kevin Hatton, MD, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2020
Primary Completion (Actual)
February 13, 2020
Study Completion (Actual)
February 13, 2020
Study Registration Dates
First Submitted
February 12, 2020
First Submitted That Met QC Criteria
February 12, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 20, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 54012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Injuries, Traumatic
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Hospital Sírio-LibanêsUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
Technical University of MunichFederal Ministry of Defence (Germany); Bundesministerium der VerteidigungRecruitingTraumatic Brain InjuriesFrance, Germany
-
Eunice Kennedy Shriver National Institute of Child...CompletedTraumatic Brain Injuries
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
University of Alabama at BirminghamCompletedTraumatic Brain InjuriesUnited States
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingConcussion, Brain | Brain Injury Traumatic MildUnited States
-
Washington University School of MedicineTerminated