Journal of Clinical and Translational Science (Jan 2024)
Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks
- Anusha Yarava,
- Christi Marshall,
- David E. Reichert,
- Aaron Ye,
- Preeti Khanal,
- Sanford H. Robbins,
- Bruce S. Sachais,
- David Oh,
- Ryan A. Metcalf,
- Kathleen Conry-Cantilena,
- Karen King,
- Meredith Reyes,
- Jill Adamski,
- Marisa B. Marques,
- Minh-Ha Tran,
- Elizabeth S. Allen,
- Daniel Pach,
- Neil Blumberg,
- Rhonda Hobbs,
- Tammon Nash,
- Aarthi G. Shenoy,
- Giselle S. Mosnaim,
- Yuriko Fukuta,
- Bela Patel,
- Sonya L. Heath,
- Adam C. Levine,
- Barry R. Meisenberg,
- Shweta Anjan,
- Moises A. Huaman,
- Janis E. Blair,
- Judith S. Currier,
- James H. Paxton,
- William Rausch,
- Kevin Oei,
- Matthew Abinante,
- Donald N. Forthal,
- Martin S. Zand,
- Seble G. Kassaye,
- Edward R. Cachay,
- Kelly A. Gebo,
- Shmuel Shoham,
- Arturo Casadevall,
- Nichol A. McBee,
- Daniel Amirault,
- Ying Wang,
- Erica Hopkins,
- David M. Shade,
- Oliver Layendecker,
- Sabra L. Klein,
- Han-Sol Park,
- John S. Lee,
- Patrizio Caturegli,
- Jay S. Raval,
- Daniel Cruser,
- Alyssa F. Ziman,
- Jonathan Gerber,
- Thomas J. Gniadek,
- Evan M. Bloch,
- Aaron A.R. Tobian,
- Daniel F. Hanley,
- David J. Sullivan,
- Karen Lane,
- the CSSC (COVID 19 Serologic Studies Consortium) group
Affiliations
- Anusha Yarava
- ORCiD
- Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Christi Marshall
- Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- David E. Reichert
- Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Aaron Ye
- Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Preeti Khanal
- Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Sanford H. Robbins
- Department of Pathology, Luminis Health, Anne Arundel Medical Center Blood Center, Annapolis, MD, USA
- Bruce S. Sachais
- New York Blood Center Enterprises, New York, NY, USA
- David Oh
- Hoxworth Blood Center, University of Cincinnati, Cincinnati, OH, USA
- Ryan A. Metcalf
- Department of Pathology, University of Utah School of Medicine, Salt Lake City, UT, USA
- Kathleen Conry-Cantilena
- Department of Pathology, MedStar Washington Hospital Center, Washington, DC, USA
- Karen King
- Department of Pathology, Rhode Island Hospital, Brown University, Providence, RI, USA
- Meredith Reyes
- Department of Pathology, Baylor College of Medicine, Houston, TX, USA
- Jill Adamski
- Department of Laboratory Medicine and Pathology, Mayo Clinic Hospital, Phoenix, AZ, USA
- Marisa B. Marques
- Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA
- Minh-Ha Tran
- Department of Pathology, University of California, Irvine, CA, USA
- Elizabeth S. Allen
- Department of Pathology, University of California, San Diego, CA, USA
- Daniel Pach
- Department of Pathology, Hoag Memorial Hospital, Newport Beach, CA, USA
- Neil Blumberg
- Department of Department of Pathology and Laboratory Medicine, Transfusion Medicine Division, University of Rochester Medical Center, Rochester, NY, USA
- Rhonda Hobbs
- Department of Laboratory Medicine, Memorial Hermann Texas Medical Center, Houston, TX, USA
- Tammon Nash
- Department of Pathology, Wayne State University, Detroit, MI, USA
- Aarthi G. Shenoy
- Department of Medicine, Division of Hematology and Oncology, MedStar Washington Hospital Center, Washington, DC, USA
- Giselle S. Mosnaim
- Division of Allergy and Immunology, Department of Medicine, Endeavor Health, Evanston, IL, USA
- Yuriko Fukuta
- Department of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX, USA
- Bela Patel
- Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Health Science Center, Houston, TX, USA
- Sonya L. Heath
- Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, USA
- Adam C. Levine
- Department of Emergency Medicine, Rhode Island Hospital, Brown University, Providence, RI, USA
- Barry R. Meisenberg
- Department of Medicine, Luminis Health, Annapolis, MD, USA
- Shweta Anjan
- Department of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA
- Moises A. Huaman
- Department of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati, OH, USA
- Janis E. Blair
- Department of Medicine, Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, AZ, USA
- Judith S. Currier
- Department of Medicine, Division of Infectious Diseases, University of California, Los Angeles, CA, USA
- James H. Paxton
- Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, MI, USA
- William Rausch
- Nuvance Health, Danbury, CT, USA
- Kevin Oei
- Ascada Research, Fullerton, CA, USA
- Matthew Abinante
- Ascada Research, Fullerton, CA, USA
- Donald N. Forthal
- Department of Medicine, Division of Infectious Diseases, University of California, Irvine School of Medicine, Irvine, CA, USA
- Martin S. Zand
- ORCiD
- Department of Medicine, University of Rochester Medical Center, Rochester, NY, USA
- Seble G. Kassaye
- Department of Medicine, Division of Infectious Diseases, Georgetown University Medical Center, Washington, DC, USA
- Edward R. Cachay
- Department of Medicine, Division of Infectious Diseases, University of California, San Diego, CA, USA
- Kelly A. Gebo
- Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Shmuel Shoham
- Department of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Arturo Casadevall
- W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
- Nichol A. McBee
- Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Daniel Amirault
- ORCiD
- Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Ying Wang
- Yale Center for Clinical Investigation, Yale University School of Medicine, New Haven, CT, USA
- Erica Hopkins
- Aerotek, Hanover, MD, USA
- David M. Shade
- Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
- Oliver Layendecker
- Division of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
- Sabra L. Klein
- W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
- Han-Sol Park
- W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
- John S. Lee
- W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
- Patrizio Caturegli
- Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Jay S. Raval
- Department of Pathology, University of New Mexico School of Medicine, Albuquerque, NM, USA
- Daniel Cruser
- Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, NY, USA
- Alyssa F. Ziman
- Department of Pathology and Laboratory Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
- Jonathan Gerber
- 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
- Thomas J. Gniadek
- Department of Pathology and Laboratory Medicine, Endeavor Health, Evanston, IL, USA
- Evan M. Bloch
- Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Aaron A.R. Tobian
- Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- Daniel F. Hanley
- ORCiD
- Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- David J. Sullivan
- ORCiD
- 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
- Karen Lane
- ORCiD
- Department of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA
- the CSSC (COVID 19 Serologic Studies Consortium) group
- DOI
- https://doi.org/10.1017/cts.2024.642
- Journal volume & issue
-
Vol. 8
Abstract
Abstract 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.
Keywords
- COVID-19
- convalescent plasma
- decentralized clinical trial
- clinical trial management
- supply chain management
- investigational drug services
- cloud-based platform
