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

Conditions
Traumatic Intracranial Hemorrhage
Interventions
Diagnostic Test: Repeat Thromboelastography with Platelet Mapping
Registration Number
NCT06433622
Lead Sponsor
Lancaster General Hospital
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.

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
225
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Repeat TEG-PMRepeat Thromboelastography with Platelet MappingWill receive a repeat TEG-PM after platelet transfusion based on inclusion criteria.
Primary Outcome Measures
NameTimeMethod
Repeat TEG1 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.

Repeat Head CTFrom 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 Outcome Measures
NameTimeMethod
Need for Neurosurgical InterventionDuring 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)

Discharge StatusFrom 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.

Trial Locations

Locations (1)

Penn Medicine Lancaster General Health

🇺🇸

Lancaster, Pennsylvania, United States

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