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

Официальное название

Platelet Transfusion and Repeat Thromboelastography With Platelet Mapping (TEG-PM) in Patients With Severe Traumatic Brain Injuries (TBI) on Antiplatelet Therapy

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Repeat TEG [Срок оценки: 1 hour after platelets given]
• Repeat Head CT [Срок оценки: From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks.]

Вторичные конечные точки (2)

• Need for Neurosurgical Intervention [Срок оценки: During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.]
• Discharge Status [Срок оценки: 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.]

Критерии участия

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

Exclusion Criteria for Retrospective Portion of Study:

• Abbreviated Injury Scale (AIS) >1 in body regions other than head because of concomitant long bone fracture or solid organ injury
• Under 18 years of age

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• Penn Medicine Lancaster General Health — Lancaster

Публикации

• 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. PMID 20298955
• 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
• 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
• 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/tsaco-2020-000520. eCollection 2020. PMID 33294625
• 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/neu.2015.4393. Epub 2016 May 9. PMID 26979949
• 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/s00701-021-04816-0. Epub 2021 Mar 26. PMID 33770261
• 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
• 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

Идентификаторы

NCT: NCT06433622 · 2023-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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