## Protocol Section
### Identification Module
**NCT ID:** NCT06433622

**Brief Title:** 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 in Patients With Severe Traumatic Brain Injuries on Antiplatelet Therapy

#### Organization Study ID Info
**ID:** 2023-47
#### Organization
**Class:** OTHER
**Full Name:** Lancaster General Hospital
### Status Module
#### Completion Date
**Date:** 2027-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Lancaster General Hospital

#### Responsible Party

**Investigator Affiliation:** Lancaster General Hospital

**Investigator Full Name:** Lindsey Perea

**Investigator Title:** Trauma and Acute Care Surgeon

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 thromboeleastography 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.

### Conditions Module

**Conditions:**

- Traumatic Intracranial Hemorrhage

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 225

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Will receive a repeat TEG-PM after platelet transfusion based on inclusion criteria.

**Intervention Names:**

- Diagnostic Test: Repeat Thromboelastography with Platelet Mapping

**Label:** Repeat TEG-PM

#### Arm Group 2

**Description:** Not eligible to be consented; will proceed with normal course of treatment.

**Label:** No Repeat TEG-PM

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Repeat TEG-PM

**Description:** 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.

**Name:** Repeat Thromboelastography with Platelet Mapping

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Other Outcomes

**Description:** Determine the efficacy of platelet transfusion among this patient cohort by measuring mortality rate.

**Measure:** Mortality

**Time Frame:** During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an averge of 2 years.

#### Primary Outcomes

**Description:** 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.

**Measure:** Repeat TEG

**Time Frame:** 1 hour after platelets given

**Description:** Number of patients with improved platelet function on repeat TEG-PM and stability of TICH on subsequent CT scan.

**Measure:** Repeat Head CT

**Time Frame:** From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks.

#### Secondary Outcomes

**Description:** 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)

**Measure:** Need for Neurosurgical Intervention

**Time Frame:** During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.

**Description:** Determine the efficacy of platelet transfusion among this patient cohort by reviewing discharge status.

**Measure:** Discharge Status

**Time Frame:** 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.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria for Interventional Portion of Study:

* Patients ≥ 18 years of age who present with isolated TICH meeting 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 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

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:

* AIS \>1 in body regions other than head
* Under 18 years of age

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The targeted population includes patients ≥ 18 years of age who present to Penn Medicine Lancaster General Health with isolated TICH. Selection of subjects is based on all adult patients presenting with isolated TICH that are admitted to Lancaster General Health Trauma Center.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lancaster

**Country:** United States

**Facility:** Penn Medicine Lancaster General Health

**State:** Pennsylvania

**Zip:** 17602

#### Overall Officials

**Official 1:**

**Affiliation:** Penn Medicine Lancaster General Health

**Name:** Lindsey Perea, DO

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 20298955

**Citation:** 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.

**PMID:** 28622955

**Citation:** Pace WD. Daily Low-Dose Aspirin, Diabetes, and Age-Still Looking for a Balance. JAMA Netw Open. 2021 Jun 1;4(6):e2112875. doi: 10.1001/jamanetworkopen.2021.12875. No abstract available.

**PMID:** 34152422

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**PMID:** 33294625

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**PMID:** 26979949

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**PMID:** 33770261

**Citation:** Peck KA, Calvo RY, Schechter MS, Sise CB, Kahl JE, Shackford MC, Shackford SR, Sise MJ, Blaskiewicz DJ. The impact of preinjury anticoagulants and prescription antiplatelet agents on outcomes in older patients with traumatic brain injury. J Trauma Acute Care Surg. 2014 Feb;76(2):431-6. doi: 10.1097/TA.0000000000000107.

**PMID:** 24458049

**Citation:** Fabbri A, Servadei F, Marchesini G, Bronzoni C, Montesi D, Arietta L; Societa Italiana di Medicina d'Emergenza Urgenza Study Group. Antiplatelet therapy and the outcome of subjects with intracranial injury: the Italian SIMEU study. Crit Care. 2013 Mar 21;17(2):R53. doi: 10.1186/cc12575.

**PMID:** 23514619

**Citation:** Joseph B, Pandit V, Aziz H, Kulvatunyou N, Hashmi A, Tang A, O'Keeffe T, Wynne J, Vercruysse G, Friese RS, Rhee P. Clinical outcomes in traumatic brain injury patients on preinjury clopidogrel: a prospective analysis. J Trauma Acute Care Surg. 2014 Mar;76(3):817-20. doi: 10.1097/TA.0b013e3182aafcf0.

**PMID:** 24553554

**Citation:** Van Ornam J, Pruitt P, Borczuk P. Is repeat head CT necessary in patients with mild traumatic intracranial hemorrhage. Am J Emerg Med. 2019 Sep;37(9):1694-1698. doi: 10.1016/j.ajem.2018.12.012. Epub 2018 Dec 10.

**PMID:** 30559018

**Citation:** Shammassian BH, Ronald A, Smith A, Sajatovic M, Mangat HS, Kelly ML. Viscoelastic Hemostatic Assays and Outcomes in Traumatic Brain Injury: A Systematic Literature Review. World Neurosurg. 2022 Mar;159:221-236.e4. doi: 10.1016/j.wneu.2021.10.180. Epub 2021 Nov 27.

**PMID:** 34844010

**Citation:** Fleming K, Redfern RE, March RL, Bobulski N, Kuehne M, Chen JT, Moront M. TEG-Directed Transfusion in Complex Cardiac Surgery: Impact on Blood Product Usage. J Extra Corpor Technol. 2017 Dec;49(4):283-290.

**PMID:** 29302119

**Citation:** Fan D, Ouyang Z, Ying Y, Huang S, Tao P, Pan X, Lu S, Pan Q. Thromboelastography for the Prevention of Perioperative Venous Thromboembolism in Orthopedics. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221077975. doi: 10.1177/10760296221077975.

**PMID:** 35379018

**Citation:** Rao A, Lin A, Hilliard C, Fu R, Lennox T, Barbosa R, Schreiber M, Rowell S. The Utility of Thromboelastography for Predicting The Risk of Progression of Intracranial Hemorrhage in Traumatic Brain Injury Patients. Neurosurgery. 2017 Sep 1;64(CN_suppl_1):182-187. doi: 10.1093/neuros/nyx210. No abstract available.

**PMID:** 28899039

**Citation:** Kay AB, Morris DS, Collingridge DS, Majercik S. Platelet dysfunction on thromboelastogram is associated with severity of blunt traumatic brain injury. Am J Surg. 2019 Dec;218(6):1134-1137. doi: 10.1016/j.amjsurg.2019.09.024. Epub 2019 Sep 23.

**PMID:** 31575420

**Citation:** 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.

**PMID:** 22847397

**Citation:** Nekludov M, Bellander BM, Blomback M, Wallen HN. Platelet dysfunction in patients with severe traumatic brain injury. J Neurotrauma. 2007 Nov;24(11):1699-706. doi: 10.1089/neu.2007.0322.

**PMID:** 18001200

**Citation:** Daley MJ, Enright Z, Nguyen J, Ali S, Clark A, Aydelotte JD, Teixeira PG, Coopwood TB, Brown CV. Adenosine diphosphate platelet dysfunction on thromboelastogram is independently associated with increased morality in traumatic brain injury. Eur J Trauma Emerg Surg. 2017 Feb;43(1):105-111. doi: 10.1007/s00068-016-0643-z. Epub 2016 Feb 18.

**PMID:** 26888580

**Citation:** Cannon JW, Dias JD, Kumar MA, Walsh M, Thomas SG, Cotton BA, Schuster JM, Evans SL, Schreiber MA, Adam EH, Zacharowski K, Hartmann J, Schochl H, Kaplan LJ. Use of Thromboelastography in the Evaluation and Management of Patients With Traumatic Brain Injury: A Systematic Review and Meta-Analysis. Crit Care Explor. 2021 Sep 14;3(9):e0526. doi: 10.1097/CCE.0000000000000526. eCollection 2021 Sep.

**PMID:** 34549189

**Citation:** Lee J, Kim JK, Kim JH, Dunuu T, Park SH, Park SJ, Kang JY, Choi RK, Hyon MS. Recovery time of platelet function after aspirin withdrawal. Curr Ther Res Clin Exp. 2014 Mar 25;76:26-31. doi: 10.1016/j.curtheres.2014.02.002. eCollection 2014 Dec.

**PMID:** 25031665

**Citation:** Glass NE, Riccardi J, Horng H, Kacprzynski G, Sifri Z. Platelet dysfunction in patients with traumatic intracranial hemorrhage: Do desmopressin and platelet therapy help or harm? Am J Surg. 2022 Jan;223(1):131-136. doi: 10.1016/j.amjsurg.2021.07.050. Epub 2021 Aug 3.

**PMID:** 34446216

**Citation:** Wolff C, Muakkassa F, Marley R, El-Khatib A, Docherty C, Muakkassa L, Stephen H, Salvator A. Routine platelet transfusion in patients with traumatic intracranial hemorrhage taking antiplatelet medication: Is it warranted? Can J Surg. 2022 Mar 15;65(2):E206-E211. doi: 10.1503/cjs.018120. Print 2022 Mar-Apr.

**PMID:** 35292527

**Citation:** Miles MVP, Hicks RC, Parmer H, Brown C, Edwards A, Stewart K, Gao L, Maxwell R. Traumatic brain injury patients with platelet inhibition receiving platelet transfusion demonstrate decreased need for neurosurgical intervention and decreased mortality. J Trauma Acute Care Surg. 2022 Apr 1;92(4):701-707. doi: 10.1097/TA.0000000000003516.

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**Citation:** Jehan F, Zeeshan M, Kulvatunyou N, Khan M, O'Keeffe T, Tang A, Gries L, Joseph B. Is There a Need for Platelet Transfusion After Traumatic Brain Injury in Patients on P2Y12 Inhibitors? J Surg Res. 2019 Apr;236:224-229. doi: 10.1016/j.jss.2018.11.050. Epub 2018 Dec 20.

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**PMID:** 29341793

#### See Also Links

**Label:** United Zion Retirement Community. Why Retire to Lititz in Lancaster County? Retirement Advice. February 11, 2019.

**URL:** http://www.uzrc.org/blog/retirement-advice/retire-to-lititz/

**Label:** Word Population Review. Lancaster County, Pennsylvania Population 2022. World Population Review. 2022.

**URL:** https://worldpopulationreview.com/us-counties/pa/lancaster-county-population

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M22113

- Name: Intracranial Hemorrhages

- Relevance: HIGH

- As Found: Intracranial Hemorrhage

- ID: M22025

- Name: Intracranial Hemorrhage, Traumatic

- Relevance: HIGH

- As Found: Traumatic Intracranial Hemorrhage

- ID: M5207

- Name: Brain Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M628

- Name: Brain Injuries, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020300

- Term: Intracranial Hemorrhages

- ID: D000020198

- Term: Intracranial Hemorrhage, Traumatic

- ID: D000006470

- Term: Hemorrhage

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M3595

- Name: Adenosine

- Relevance: LOW

- As Found: Unknown

- ID: T362

- Name: Arachidonic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
