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

NCT06433622 | Enrolling By Invitation

• 1 other identifier: 2023-47
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Intracranial Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Repeat TEG

  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

  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 Outcomes (2)

• Need for Neurosurgical Intervention

  During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.

• 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 Outcomes (1)

• Mortality

  During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.

Study Arms (2)

Repeat TEG-PM

Will receive a repeat TEG-PM after platelet transfusion based on inclusion criteria.

Diagnostic Test: Repeat Thromboelastography with Platelet Mapping

No Repeat TEG-PM

Not eligible to be consented; will proceed with normal course of treatment.

Interventions

Repeat Thromboelastography with Platelet Mapping DIAGNOSTIC_TEST

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.

Repeat TEG-PM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lancaster General Hospital: lead

Study Sites (1)

Penn Medicine Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

Location

Related Publications (28)

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Related Links

• Get the facts about TBI. Centers for Disease Control and Prevention.
• Facts about falls. Centers for Disease Control and Prevention.
• TBI data. Centers for Disease Control and Prevention.
• United Zion Retirement Community. Why Retire to Lititz in Lancaster County? Retirement Advice. February 11, 2019.
• Word Population Review. Lancaster County, Pennsylvania Population 2022. World Population Review. 2022.

MeSH Terms

Conditions

Intracranial Hemorrhage, Traumatic

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• Lindsey Perea, DO

  Penn Medicine Lancaster General Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trauma and Acute Care Surgeon

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 30, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)