Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks.

Autor:	Yarava A; Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Marshall C; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Reichert DE; Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Ye A; Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Khanal P; Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Robbins SH; Department of Pathology, Luminis Health, Anne Arundel Medical Center Blood Center, Annapolis, MD, USA., Sachais BS; New York Blood Center Enterprises, New York, NY, USA., Oh D; Hoxworth Blood Center, University of Cincinnati, Cincinnati, OH, USA., Metcalf RA; Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, USA., Conry-Cantilena K; Department of Pathology, MedStar Washington Hospital Center, Washington, DC, USA., King K; Department of Pathology, Rhode Island Hospital, Brown University, Providence, RI, USA., Reyes M; Department of Pathology, Baylor College of Medicine, Houston, TX, USA., Adamski J; Department of Laboratory Medicine and Pathology, Mayo Clinic Hospital, Phoenix, AZ, USA., Marques MB; Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA., Tran MH; Department of Pathology, University of California, Irvine, CA, USA., Allen ES; Department of Pathology, University of California, San Diego, CA, USA., Pach D; Department of Pathology, Hoag Memorial Hospital, Newport Beach, CA, USA., Blumberg N; Department of Department of Pathology and Laboratory Medicine, Transfusion Medicine Division, University of Rochester Medical Center, Rochester, NY, USA., Hobbs R; Department of Laboratory Medicine, Memorial Hermann Texas Medical Center, Houston, TX, USA., Nash T; Department of Pathology, Wayne State University, Detroit, MI, USA., Shenoy AG; Department of Medicine, Division of Hematology and Oncology, MedStar Washington Hospital Center, Washington, DC, USA., Mosnaim GS; Division of Allergy and Immunology, Department of Medicine, Endeavor Health, Evanston, IL, USA., Fukuta Y; Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX, USA., Patel B; Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Health Science Center, Houston, TX, USA., Heath SL; Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, USA., Levine AC; Department of Emergency Medicine, Rhode Island Hospital, Brown University, Providence, RI, USA., Meisenberg BR; Department of Medicine, Luminis Health, Annapolis, MD, USA., Anjan S; Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA., Huaman MA; Department of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati, OH, USA., Blair JE; Department of Medicine, Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, AZ, USA., Currier JS; Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, CA, USA., Paxton JH; Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, MI, USA., Rausch W; Nuvance Health, Danbury, CT, USA., Oei K; Ascada Research, Fullerton, CA, USA., Abinante M; Ascada Research, Fullerton, CA, USA., Forthal DN; Department of Medicine, Division of Infectious Diseases, University of California, Irvine School of Medicine, Irvine, CA, USA., Zand MS; Department of Medicine, University of Rochester Medical Center, Rochester, NY, USA., Kassaye SG; Department of Medicine, Division of Infectious Diseases, Georgetown University Medical Center, Washington, DC, USA., Cachay ER; Department of Medicine, Division of Infectious Diseases, University of California, San Diego, CA, USA., Gebo KA; Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Shoham S; Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Casadevall A; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., McBee NA; Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Amirault D; Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Wang Y; Yale Center for Clinical Investigation, Yale University School of Medicine, New Haven, CT, USA., Hopkins E; Aerotek, Hanover, MD, USA., Shade DM; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Layendecker O; Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA., Klein SL; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Park HS; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Lee JS; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Caturegli P; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Raval JS; Department of Pathology, University of New Mexico School of Medicine, Albuquerque, NM, USA., Cruser D; Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, NY, USA., Ziman AF; Department of Pathology and Laboratory Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA., Gerber J; Department of Medicine, Division of Hematology and Oncology, University of Massachusetts Chan Medical School, Worcester, MA, USA and Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA., Gniadek TJ; Department of Pathology and Laboratory Medicine, Endeavor Health, Evanston, IL, USA., Bloch EM; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Tobian AAR; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Hanley DF; Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Sullivan DJ; Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA.; W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Lane K; Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Jazyk:	angličtina
Zdroj:	Journal of clinical and translational science [J Clin Transl Sci] 2024 Nov 14; Vol. 8 (1), pp. e200. Date of Electronic Publication: 2024 Nov 14 (Print Publication: 2024).
DOI:	10.1017/cts.2024.642
Abstrakt:	Introduction: In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety. Methods: A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites. Results: We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites. Conclusion: The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies. Competing Interests: TJG is a paid consultant and employee of Fenwal, a Fresenius Kabi company (2021–2023); Employee of Werfen (2023-present). AC is on a Scientific Advisory Board of Sabtherapeutics (cow-derived human immunoglobulins COVID-19 treatment and other infectious diseases) and Ortho Diagnostics Speakers Bureau. MAH contracts from Gilead Sciences, Insmed, AN2 Therapeutics, AstraZeneca to the University of Cincinnati, outside the submitted work. EB is a member of the FDA Blood Products Advisory Committee. SS reports research grants; F2G, Cidara, Ansun, Zeteo: personal fees as consultant, advisory board, data safety monitoring board member; Celltrion, Adagio, Immunome, Karius, Pfizer, Scynexis, Adamis, Karyopharm, Intermountain Health: Stock options: Immunome. All other authors report no relevant disclosures. (© The Author(s) 2024.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu