Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Correcting Platelet Dysfunction After Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03182946
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : April 21, 2022
Sponsor:
Collaborator:
Carolinas Medical Center
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Platelet Dysfunction Traumatic Brain Injury 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : October 1, 2017
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Diagnostic Test: Platelet mapping Thromboelastography
    These diagnostic tests will be acquired in patients with brain injury, to determine prediction of clinical, functional and psychological outcome.
    Other Names:
    • Platelet mitochondrial respiration
    • Serum presence of microparticles
    • Serum presence of cardiolipin
    • Functional independence measure

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in platelet function [ Time Frame: Within 5 hours ]
    Correction of platelet inhibition measured before and after transfusion through platelet mapping thromboelastography


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 1-3 months ]
    Mortality will be compared to admission platelet inhibition

  2. Functional Independence Measure [ Time Frame: 6-12 months ]
    Patient function as measured by Functional Independence Measure compared to platelet inhibition


Biospecimen Retention:   Samples With DNA
Blood samples from which platelet function and platelet mitochondrial function will be analyzed, as well as serum markers for mitochondrial function

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The population will be geriatric patients with moderate to severe TBI (GCS <=13).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Previously know coagulation dysfunction

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182946


Locations
Layout table for location information
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232
Sponsors and Collaborators
Wake Forest University Health Sciences
Carolinas Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Susan Evans, MD Carolinas Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03182946    
Other Study ID Numbers: 08-16-22E
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only collaborators will have patient names for data acquisition.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Blood Platelet Disorders
Wounds and Injuries
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hematologic Diseases