Clinical trial NCT03182946: Correcting Platelet Dysfunction After Traumatic Brain Injury
Official title: Correction of Platelet Dysfunction Following Traumatic Brain Injury in Geriatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Dysfunction
Traumatic Brain Injury
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Carolinas Medical Center
First posted: 2017-06-09
Enrollment: 147
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population will be geriatric patients with moderate to severe TBI (GCS \<=13).

Brief summary: This study evaluates the impact of platelet transfusion on geriatric patients with platelet dysfunction from Traumatic Brain Injury. The authors hypothesize that patients will recover better if their platelet dysfunction is corrected with platelet transfusion.

Detailed description: The geriatric population is subject to traumatic brain injury, often occurring as a result of falls. This patient population is also often receiving anticoagulants and platelet inhibitors increasing their risk of post-injury hemorrhage. Following Traumatic Brain Injury, even without platelet inhibitor medications, platelets become dysfunctional and are no longer able to assist with clot formation. Therefore risk of hemorrhage is increased, both in the brain, and other hemorrhagic sites. Clinical practice at Carolinas Medical Center is to transfuse platelets in patients with platelet dysfunction following brain injury. The current study is investigating the impact of transfusion on correction of platelet dysfunction and patient outcome.

Furthermore, stored platelet dysfunction can be corrected by supplementation with cytochrome c, which supports mitochondrial function. Therefore, the ability of cytochrome c to correct dysfunction in ex vivo platelets from patients with Traumatic Brain Injury will be assessed.

Eligibility criteria: Inclusion Criteria:

Traumatic brain injury with Glasgow Coma Scale Score (GCS) \<=13

Exclusion Criteria:

Previously know coagulation dysfunction

Primary outcomes:
measure: Change in platelet function
timeFrame: Within 5 hours
Secondary outcomes:
measure: Mortality
timeFrame: 1-3 months
measure: Functional Independence Measure
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: Susan Evans, MD
role: PRINCIPAL_INVESTIGATOR
References:
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