Correcting Platelet Dysfunction After Traumatic Brain Injury

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03182946
Collaborator
Carolinas Medical Center (Other)
147
1
45
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Platelet mapping Thromboelastography

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 Design

Study Type:
Observational
Actual Enrollment :
147 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Correction of Platelet Dysfunction Following Traumatic Brain Injury in Geriatric Patients
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Change in platelet function [Within 5 hours]

    Correction of platelet inhibition measured before and after transfusion through platelet mapping thromboelastography

Secondary Outcome Measures

  1. Mortality [1-3 months]

    Mortality will be compared to admission platelet inhibition

  2. Functional Independence Measure [6-12 months]

    Patient function as measured by Functional Independence Measure compared to platelet inhibition

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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

Exclusion Criteria:

Previously know coagulation dysfunction

Contacts and Locations

Locations

Site City State Country Postal Code
1 Carolinas Medical Center Charlotte North Carolina United States 28232

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • Carolinas Medical Center

Investigators

  • Principal Investigator: Susan Evans, MD, Carolinas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT03182946
Other Study ID Numbers:
  • 08-16-22E
First Posted:
Jun 9, 2017
Last Update Posted:
Apr 21, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2022