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Completed

NCT Number: NCT03182946

Correcting Platelet Dysfunction After Traumatic Brain Injury

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.

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Key information

Conditions

Platelet Dysfunction Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Previously know coagulation dysfunction

Treatment and study plan

Platelet mapping Thromboelastography

Diagnostic Test

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

Primary outcomes

  1. Change in platelet function

    Time frame: Within 5 hours

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Carolinas Medical Center

Registry information

Official study title

Correction of Platelet Dysfunction Following Traumatic Brain Injury in Geriatric Patients

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2017
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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