Traumatic Intracranial Hemorrhage
Conditions
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.
Interventions
DIAGNOSTIC_TESTRepeat Thromboelastography with Platelet Mapping
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.
Sponsors
Lancaster General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repeat TEG | 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. |
| Repeat Head CT | 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
| Measure | Time frame | Description |
|---|---|---|
| Need for Neurosurgical Intervention | 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) |
| 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. | Determine the efficacy of platelet transfusion among this patient cohort by reviewing discharge status. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 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. |
Countries
United States
Outcome results
None listed