Platelet Transfusion and Repeat TEG-PM in Patients With Severe TBI on Antiplatelet Therapy (Repeat TEG-PM)

October 27, 2025 updated by: Lindsey Perea, Lancaster General Hospital

Platelet Transfusion and Repeat Thromboelastography With Platelet Mapping (TEG-PM) in Patients With Severe Traumatic Brain Injuries (TBI) on Antiplatelet Therapy

The aim of this study is to see if administering platelets (cells in our blood that stop or prevent bleeding) results in improved platelet function and slows/stops the progression of a head bleed for patients who have a traumatic head bleed and are on antiplatelet therapy (medications that stop blood cells from forming a blood clot) prior to admission.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine if platelet function has improved following platelet transfusion by prospectively performing repeat thromboelastographic with platelet mapping (TEG-PM) assays on all patients consented and enrolled in the study. This study will also examine the rate of progression or stability of ICH on repeat head CT following platelet administration and will aid in the determination of a potential association between repeat CT head findings and the repeat TEG-PM results.

Study Type

Observational

Enrollment (Estimated)

225

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
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Penn Medicine Lancaster General Health

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The targeted population includes patients ≥ 18 years of age who present to Penn Medicine Lancaster General Health with TICH. Selection of subjects is based on all adult patients presenting with TICH that are admitted to Lancaster General Health Trauma Center.

Description

Inclusion Criteria for Interventional Portion of Study:

  • Patients ≥ 18 years of age who present with TICH meeting Brain Injury Guidelines (BIG) 2 or 3 head bleed criteria
  • Currently on antiplatelet medication on admission
  • Must have taken this antiplatelet medication within the past 48 hours prior to presentation
  • Patients who have AA and/or ADP inhibition of 70% or greater and Maximum Amplitude (MA) <50 will then receive a platelet transfusion and a repeat TEG-PM 1hr after transfusion

Exclusion Criteria for Interventional Portion of Study:

  • Under 18 years of age
  • Have a known bleeding diatheses
  • Current therapeutic anticoagulation use
  • Do not know the time of their last antiplatelet medication dose
  • Patients or their proxy who are unable to provide consent
  • Patients with concomitant long bone fractures or solid organ injuries

Inclusion Criteria for Retrospective Portion of Study:

• Patients with a TICH who are 18 years of age or older

Exclusion Criteria for Retrospective Portion of Study:

  • Abbreviated Injury Scale (AIS) >1 in body regions other than head because of concomitant long bone fracture or solid organ injury
  • Under 18 years of age

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Repeat TEG-PM
Will receive a repeat TEG-PM after platelet transfusion based on inclusion criteria.
Diagnostic test: Repeat Thromboelastography with Platelet Mapping
Thromboelastography (TEG) is an assay used by many medical professionals to assess coagulopathy, predict outcomes, and guide treatment. Although TEG does not assess platelet function very well, a TEG with platelet mapping (TEG-PM) assay assesses platelet functioning by measuring the percent of arachidonic acid (AA) and adenosine diphosphate (ADP) that are inhibited in the patient's blood.
No Repeat TEG-PM
Not eligible to be consented; will proceed with normal course of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeat TEG
Time Frame: 1 hour after platelets given
Rate of reversed pathway inhibition on repeat thromboelastography with platelet mapping (TEG-PM) when platelets are administered to TICH patients who are on antiplatelet therapy prior to admission.
1 hour after platelets given
Repeat Head CT
Time Frame: From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks.
Number of patients with improved platelet function on repeat TEG-PM and stability of TICH on subsequent CT scan.
From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for Neurosurgical Intervention
Time Frame: During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.
Determine the efficacy of platelet transfusion among this patient cohort by measuring need for neurosurgical intervention after second CT scan (ie: the failure of non-operative management)
During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.
Discharge Status
Time Frame: From the time of interventional platelet administration until the time of patient discharge from their index admission assessed through study completion, an average of 2 years.
Determine the efficacy of platelet transfusion among this patient cohort by reviewing discharge status.
From the time of interventional platelet administration until the time of patient discharge from their index admission assessed through study completion, an average of 2 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.
Determine the efficacy of platelet transfusion among this patient cohort by measuring mortality rate.
During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.

Collaborators and Investigators

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

Sponsor

Lancaster General Hospital

Investigators

  • Principal Investigator: Lindsey Perea, DO, Penn Medicine Lancaster General Health

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

Helpful Links

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)

December 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 27, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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