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

Traumatic Intracranial Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06433622
• Other study ID #: 2023-47
• Status: Enrolling by invitation
• Start date: December 1, 2023
• Est. completion date: November 2027

Study information

• Verified date: June 2024
• Source: Lancaster General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 225
• Est. completion date: November 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Interventional Portion of Study:

• Patients = 18 years of age who present with isolated 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

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

• Under 18 years of age

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhage, Traumatic
• Intracranial Hemorrhages
• Traumatic Intracranial Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	Penn Medicine Lancaster General Health	Lancaster	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lancaster General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (28)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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: 10.1080/02699052.2018.1425804. Epub 2018 Jan 17. — View 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. — View 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. — View Citation

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/TA.0b013e3182a96591. — View 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. — View 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. — View 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. — View Citation

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/j.jss.2020.07.076. Epub 2020 Aug 27. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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/j.bpa.2009.11.001. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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
Primary	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.
Secondary	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.
Secondary	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.

External Links

•   Facts about falls. Centers for Disease Control and Prevention.
•   Get the facts about TBI. Centers for Disease Control and Prevention.
•   TBI data. Centers for Disease Control and Prevention.
•   United Zion Retirement Community. Why Retire to Lititz in Lancaster County? Retirement Advice. February 11, 2019.
•   Word Population Review. Lancaster County, Pennsylvania Population 2022. World Population Review. 2022.