Clinical trial NCT06433622: Platelet Transfusion and Repeat TEG-PM in Patients With Severe TBI on Antiplatelet Therapy (Repeat TEG-PM)
Official title: Platelet Transfusion and Repeat Thromboelastography With Platelet Mapping (TEG-PM) in Patients With Severe Traumatic Brain Injuries (TBI) on Antiplatelet Therapy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Traumatic Intracranial Hemorrhage
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Repeat TEG
timeFrame: 1 hour after platelets given
measure: Repeat Head CT
timeFrame: From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks.
Secondary outcomes:
measure: Need for Neurosurgical Intervention
timeFrame: During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.
measure: Discharge Status
timeFrame: 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:
measure: Mortality
timeFrame: During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.
Locations:
city: Lancaster
country: United States
facility: Penn Medicine Lancaster General Health
state: Pennsylvania
Study officials:
affiliation: Penn Medicine Lancaster General Health
name: Lindsey Perea, DO
role: PRINCIPAL_INVESTIGATOR
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