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

Lancaster General Hospital

Status

Invitation-only

Conditions

Traumatic Intracranial Hemorrhage

Treatments

Diagnostic Test: Repeat Thromboelastography with Platelet Mapping

Study type

Observational

Funder types

Other

Identifiers

NCT06433622

2023-47

Details and patient eligibility

About

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.

Full 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.

Enrollment

225 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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