Correcting Platelet Dysfunction After Traumatic Brain Injury

Completed

• Conditions: Platelet Dysfunction; Traumatic Brain Injury

• Registration Number: NCT03182946
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Study Start: 2017-10-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

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

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Exclusion Criteria

Previously know coagulation dysfunction

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in platelet function	Within 5 hours	Correction of platelet inhibition measured before and after transfusion through platelet mapping thromboelastography

Secondary Outcome Measures

Name	Time	Method
Functional Independence Measure	6-12 months	Patient function as measured by Functional Independence Measure compared to platelet inhibition
Mortality	1-3 months	Mortality will be compared to admission platelet inhibition

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States