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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repeat TEG-PM | Will receive a repeat TEG-PM after platelet transfusion based on inclusion criteria. |
| |
| No Repeat TEG-PM | Not eligible to be consented; will proceed with normal course of treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Repeat TEG | 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. | 1 hour after platelets given |
| Repeat Head CT | Number of patients with improved platelet function on repeat TEG-PM and stability of TICH on subsequent CT scan. | From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Neurosurgical Intervention | 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) | During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Determine the efficacy of platelet transfusion among this patient cohort by measuring mortality rate. | During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years. |
Inclusion Criteria for Interventional Portion of Study:
Exclusion Criteria for Interventional Portion of Study:
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Perea, DO | Penn Medicine Lancaster General Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine Lancaster General Health | Lancaster | Pennsylvania | 17602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20298955 | Background | Traumatic brain injury: time to end the silence. Lancet Neurol. 2010 Apr;9(4):331. doi: 10.1016/S1474-4422(10)70069-7. No abstract available. | |
| 28622955 | Background | Li L, Geraghty OC, Mehta Z, Rothwell PM; Oxford Vascular Study. Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study. Lancet. 2017 Jul 29;390(10093):490-499. doi: 10.1016/S0140-6736(17)30770-5. Epub 2017 Jun 13. |
| Label | URL |
|---|---|
| Get the facts about TBI. Centers for Disease Control and Prevention. | View source |
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| ID | Term |
|---|---|
| D020198 | Intracranial Hemorrhage, Traumatic |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Discharge Status | Determine the efficacy of platelet transfusion among this patient cohort by reviewing 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. |
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| 22847397 | Background | Davis PK, Musunuru H, Walsh M, Cassady R, Yount R, Losiniecki A, Moore EE, Wohlauer MV, Howard J, Ploplis VA, Castellino FJ, Thomas SG. Platelet dysfunction is an early marker for traumatic brain injury-induced coagulopathy. Neurocrit Care. 2013 Apr;18(2):201-8. doi: 10.1007/s12028-012-9745-6. |
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| Facts about falls. Centers for Disease Control and Prevention. | View source |
| TBI data. Centers for Disease Control and Prevention. | View source |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014947 | Wounds and Injuries |