Correcting Platelet Dysfunction After Traumatic Brain Injury

April 19, 2022 updated by: Wake Forest University Health Sciences

Correction of Platelet Dysfunction Following Traumatic Brain Injury in Geriatric Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

147

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

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28232
        • Carolinas 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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The population will be geriatric patients with moderate to severe TBI (GCS <=13).

Description

Inclusion Criteria:

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

Exclusion Criteria:

Previously know coagulation dysfunction

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in platelet function
Time Frame: Within 5 hours
Correction of platelet inhibition measured before and after transfusion through platelet mapping thromboelastography
Within 5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 1-3 months
Mortality will be compared to admission platelet inhibition
1-3 months
Functional Independence Measure
Time Frame: 6-12 months
Patient function as measured by Functional Independence Measure compared to platelet inhibition
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Carolinas Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2017

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-16-22E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only collaborators will have patient names for data acquisition.

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 Traumatic Brain Injury

Clinical Trials on Platelet mapping Thromboelastography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe