[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06433622":3,"trial-entities:NCT06433622":186,"trial-summary:NCT06433622":192},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":43,"sex":52,"minimum_age":53,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":69,"locations":72,"central_contacts":82,"overall_officials":83,"references":87,"see_also_links":173},"NCT06433622","2023-47","Platelet Transfusion and Repeat TEG-PM in Patients With Severe TBI on Antiplatelet Therapy (Repeat TEG-PM)","Platelet Transfusion and Repeat Thromboelastography With Platelet Mapping (TEG-PM) in Patients With Severe Traumatic Brain Injuries (TBI) on Antiplatelet Therapy","ENROLLING_BY_INVITATION","2027-11","2025-10","2025-10-29","2023-12-01","Lancaster General Hospital","OTHER",false,"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\u002Fstops 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.",[19],"Traumatic Intracranial Hemorrhage",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},225,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIAGNOSTIC_TEST","Repeat 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.",[33],"Repeat TEG-PM",[35,39],{"measure":36,"description":37,"timeFrame":38},"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",{"measure":40,"description":41,"timeFrame":42},"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.",[44,48],{"measure":45,"description":46,"timeFrame":47},"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":49,"description":50,"timeFrame":51},"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.","ALL","18 Years",{"inclusion":55,"exclusion":60,"raw_text":68},[56,57,58,59],"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\u002For ADP inhibition of 70% or greater and Maximum Amplitude (MA) \\\u003C50 will then receive a platelet transfusion and a repeat TEG-PM 1hr after transfusion",[61,62,63,64,65,66,67,61],"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","Abbreviated Injury Scale (AIS) \\>1 in body regions other than head because of concomitant long bone fracture or solid organ injury","Inclusion Criteria for Interventional Portion of Study:\n\n* Patients ≥ 18 years of age who present with TICH meeting Brain Injury Guidelines (BIG) 2 or 3 head bleed criteria\n* Currently on antiplatelet medication on admission\n* Must have taken this antiplatelet medication within the past 48 hours prior to presentation\n* Patients who have AA and\u002For ADP inhibition of 70% or greater and Maximum Amplitude (MA) \\\u003C50 will then receive a platelet transfusion and a repeat TEG-PM 1hr after transfusion\n\nExclusion Criteria for Interventional Portion of Study:\n\n* Under 18 years of age\n* Have a known bleeding diatheses\n* Current therapeutic anticoagulation use\n* Do not know the time of their last antiplatelet medication dose\n* Patients or their proxy who are unable to provide consent\n* Patients with concomitant long bone fractures or solid organ injuries\n\nInclusion Criteria for Retrospective Portion of Study:\n\n• Patients with a TICH who are 18 years of age or older\n\nExclusion Criteria for Retrospective Portion of Study:\n\n* Abbreviated Injury Scale (AIS) \\>1 in body regions other than head because of concomitant long bone fracture or solid organ injury\n* Under 18 years of age",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"Penn Medicine Lancaster General Health","Lancaster","Pennsylvania","17602","United States",{"lat":80,"lon":81},40.03788,-76.30551,[],[84],{"name":85,"affiliation":74,"role":86},"Lindsey Perea, DO","PRINCIPAL_INVESTIGATOR",[88,92,95,98,101,104,107,110,113,116,119,122,125,128,131,134,137,140,143,146,149,152,155,158,161,164,167,170],{"pmid":89,"type":90,"citation":91},"20298955","BACKGROUND","Traumatic brain injury: time to end the silence. Lancet Neurol. 2010 Apr;9(4):331. doi: 10.1016\u002FS1474-4422(10)70069-7. No abstract available.",{"pmid":93,"type":90,"citation":94},"28622955","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\u002FS0140-6736(17)30770-5. Epub 2017 Jun 13.",{"pmid":96,"type":90,"citation":97},"34152422","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\u002Fjamanetworkopen.2021.12875. No abstract available.",{"pmid":99,"type":90,"citation":100},"33294625","Alter SM, Mazer BA, Solano JJ, Shih RD, Hughes MJ, Clayton LM, Greaves SW, Trinh NQ, Hughes PG. Antiplatelet therapy is associated with a high rate of intracranial hemorrhage in patients with head injuries. Trauma Surg Acute Care Open. 2020 Nov 25;5(1):e000520. doi: 10.1136\u002Ftsaco-2020-000520. eCollection 2020.",{"pmid":102,"type":90,"citation":103},"26979949","van den Brand CL, Tolido T, Rambach AH, Hunink MG, Patka P, Jellema K. Systematic Review and Meta-Analysis: Is Pre-Injury Antiplatelet Therapy Associated with Traumatic Intracranial Hemorrhage? J Neurotrauma. 2017 Jan 1;34(1):1-7. doi: 10.1089\u002Fneu.2015.4393. Epub 2016 May 9.",{"pmid":105,"type":90,"citation":106},"33770261","Svedung Wettervik T, Lenell S, Enblad P, Lewen A. Pre-injury antithrombotic agents predict intracranial hemorrhagic progression, but not worse clinical outcome in severe traumatic brain injury. Acta Neurochir (Wien). 2021 May;163(5):1403-1413. doi: 10.1007\u002Fs00701-021-04816-0. Epub 2021 Mar 26.",{"pmid":108,"type":90,"citation":109},"24458049","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\u002FTA.0000000000000107.",{"pmid":111,"type":90,"citation":112},"23514619","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\u002Fcc12575.",{"pmid":114,"type":90,"citation":115},"24553554","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\u002FTA.0b013e3182aafcf0.",{"pmid":117,"type":90,"citation":118},"30559018","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\u002Fj.ajem.2018.12.012. Epub 2018 Dec 10.",{"pmid":120,"type":90,"citation":121},"34844010","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\u002Fj.wneu.2021.10.180. Epub 2021 Nov 27.",{"pmid":123,"type":90,"citation":124},"29302119","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":126,"type":90,"citation":127},"35379018","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\u002F10760296221077975.",{"pmid":129,"type":90,"citation":130},"28899039","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\u002Fneuros\u002Fnyx210. No abstract available.",{"pmid":132,"type":90,"citation":133},"31575420","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\u002Fj.amjsurg.2019.09.024. Epub 2019 Sep 23.",{"pmid":135,"type":90,"citation":136},"22847397","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\u002Fs12028-012-9745-6.",{"pmid":138,"type":90,"citation":139},"18001200","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\u002Fneu.2007.0322.",{"pmid":141,"type":90,"citation":142},"26888580","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\u002Fs00068-016-0643-z. Epub 2016 Feb 18.",{"pmid":144,"type":90,"citation":145},"34549189","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\u002FCCE.0000000000000526. eCollection 2021 Sep.",{"pmid":147,"type":90,"citation":148},"25031665","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\u002Fj.curtheres.2014.02.002. eCollection 2014 Dec.",{"pmid":150,"type":90,"citation":151},"34446216","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\u002Fj.amjsurg.2021.07.050. Epub 2021 Aug 3.",{"pmid":153,"type":90,"citation":154},"35292527","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\u002Fcjs.018120. Print 2022 Mar-Apr.",{"pmid":156,"type":90,"citation":157},"35320155","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\u002FTA.0000000000003516.",{"pmid":159,"type":90,"citation":160},"30694760","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\u002Fj.jss.2018.11.050. Epub 2018 Dec 20.",{"pmid":162,"type":90,"citation":163},"32862051","Lokhandwala AM, Asmar S, Khurrum M, Chehab M, Bible L, Castanon L, Ditillo M, Joseph B. Platelet Transfusion After Traumatic Intracranial Hemorrhage in Patients on Antiplatelet Agents. J Surg Res. 2021 Jan;257:239-245. doi: 10.1016\u002Fj.jss.2020.07.076. Epub 2020 Aug 27.",{"pmid":165,"type":90,"citation":166},"20402171","Spiess BD. Platelet transfusions: the science behind safety, risks and appropriate applications. Best Pract Res Clin Anaesthesiol. 2010 Mar;24(1):65-83. doi: 10.1016\u002Fj.bpa.2009.11.001.",{"pmid":168,"type":90,"citation":169},"24256671","Joseph B, Pandit V, Sadoun M, Larkins CG, Kulvatunyou N, Tang A, Mino M, Friese RS, Rhee P. A prospective evaluation of platelet function in patients on antiplatelet therapy with traumatic intracranial hemorrhage. J Trauma Acute Care Surg. 2013 Dec;75(6):990-4. doi: 10.1097\u002FTA.0b013e3182a96591.",{"pmid":171,"type":90,"citation":172},"29341793","Holzmacher JL, Reynolds C, Patel M, Maluso P, Holland S, Gamsky N, Moore H, Acquista E, Carrick M, Amdur R, Hancock H, Metzler M, Dunn J, Sarani B. Platelet transfusion does not improve outcomes in patients with brain injury on antiplatelet therapy. Brain Inj. 2018;32(3):325-330. doi: 10.1080\u002F02699052.2018.1425804. Epub 2018 Jan 17.",[174,177,180,183],{"label":175,"url":176},"Get the facts about TBI. Centers for Disease Control and Prevention.","https:\u002F\u002Fwww.cdc.gov\u002Ftraumatic-brain-injury\u002Fdata-research\u002Ffacts-stats\u002F?CDC_AAref_Val=https:\u002F\u002Fwww.cdc.gov\u002Ftraumaticbraininjury\u002Fget_the_facts.html",{"label":178,"url":179},"Facts about falls. Centers for Disease Control and Prevention.","https:\u002F\u002Fwww.cdc.gov\u002Ffalls\u002Fdata-research\u002Ffacts-stats\u002F?CDC_AAref_Val=https:\u002F\u002Fwww.cdc.gov\u002Ffalls\u002Ffacts.html",{"label":181,"url":182},"United Zion Retirement Community. Why Retire to Lititz in Lancaster County? Retirement Advice. February 11, 2019.","http:\u002F\u002Fwww.uzrc.org\u002Fblog\u002Fretirement-advice\u002Fretire-to-lititz\u002F",{"label":184,"url":185},"Word Population Review. Lancaster County, Pennsylvania Population 2022. World Population Review. 2022.","https:\u002F\u002Fworldpopulationreview.com\u002Fus-counties\u002Fpa\u002Flancaster-county-population",{"nct_id":4,"conditions":187,"biomarkers":189},[188],"Intracranial hemorrhage following injury",[190,191],"Helicoid peripapillary chorioretinal degeneration","Maximum Amplitude (MA)",{"nct_id":4,"found":15,"summary":22,"prompt_version":22}]