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Enrolling by Invitation

NCT Number: NCT06433622

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn Medicine Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Lancaster General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 30, 2024
Registry last updated
Oct 29, 2025

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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