Evidence map›Paper›PMID 39655012›Full record

ArticleJournal of clinical and translational science2024

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 and 53 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

63 authors.

Anusha YaravaDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0009-0006-9827-8829
Christi MarshallDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
David E ReichertDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Aaron YeDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Preeti KhanalDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Sanford H RobbinsDepartment of Pathology, Luminis Health, Anne Arundel Medical Center Blood Center, Annapolis, MD, USA.
Bruce S SachaisNew York Blood Center Enterprises, New York, NY, USA.
David OhHoxworth Blood Center, University of Cincinnati, Cincinnati, OH, USA.
Ryan A MetcalfDepartment of Pathology, University of Utah School of Medicine, Salt Lake City, UT, USA.
Kathleen Conry-CantilenaDepartment of Pathology, MedStar Washington Hospital Center, Washington, DC, USA.
Karen KingDepartment of Pathology, Rhode Island Hospital, Brown University, Providence, RI, USA.
Meredith ReyesDepartment of Pathology, Baylor College of Medicine, Houston, TX, USA.
Jill AdamskiDepartment of Laboratory Medicine and Pathology, Mayo Clinic Hospital, Phoenix, AZ, USA.
Marisa B MarquesDepartment of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA.
Minh-Ha TranDepartment of Pathology, University of California, Irvine, CA, USA.
Elizabeth S AllenDepartment of Pathology, University of California, San Diego, CA, USA.
Daniel PachDepartment of Pathology, Hoag Memorial Hospital, Newport Beach, CA, USA.
Neil BlumbergDepartment of Department of Pathology and Laboratory Medicine, Transfusion Medicine Division, University of Rochester Medical Center, Rochester, NY, USA.
Rhonda HobbsDepartment of Laboratory Medicine, Memorial Hermann Texas Medical Center, Houston, TX, USA.
Tammon NashDepartment of Pathology, Wayne State University, Detroit, MI, USA.
Aarthi G ShenoyDepartment of Medicine, Division of Hematology and Oncology, MedStar Washington Hospital Center, Washington, DC, USA.
Giselle S MosnaimDivision of Allergy and Immunology, Department of Medicine, Endeavor Health, Evanston, IL, USA.
Yuriko FukutaDepartment of Medicine, Section of Infectious Diseases, Baylor College of Medicine, Houston, TX, USA.
Bela PatelDepartment of Medicine, Division of Pulmonary and Critical Care Medicine, University of Texas Health Science Center, Houston, TX, USA.
Sonya L HeathDepartment of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, USA.
Adam C LevineDepartment of Emergency Medicine, Rhode Island Hospital, Brown University, Providence, RI, USA.
Barry R MeisenbergDepartment of Medicine, Luminis Health, Annapolis, MD, USA.
Shweta AnjanDepartment of Medicine, Division of Infectious Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.
Moises A HuamanDepartment of Medicine, Division of Infectious Diseases, University of Cincinnati, Cincinnati, OH, USA.
Janis E BlairDepartment of Medicine, Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, AZ, USA.
Judith S CurrierDepartment of Medicine, Division of Infectious Diseases, University of California, Los Angeles, CA, USA.
James H PaxtonDepartment of Emergency Medicine, Wayne State University School of Medicine, Detroit, MI, USA.
William RauschNuvance Health, Danbury, CT, USA.
Kevin OeiAscada Research, Fullerton, CA, USA.
Matthew AbinanteAscada Research, Fullerton, CA, USA.
Donald N ForthalDepartment of Medicine, Division of Infectious Diseases, University of California, Irvine School of Medicine, Irvine, CA, USA.
Martin S ZandDepartment of Medicine, University of Rochester Medical Center, Rochester, NY, USA.ORCID https://orcid.org/0000-0002-7095-8682
Seble G KassayeDepartment of Medicine, Division of Infectious Diseases, Georgetown University Medical Center, Washington, DC, USA.
Edward R CachayDepartment of Medicine, Division of Infectious Diseases, University of California, San Diego, CA, USA.
Kelly A GeboDepartment of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Shmuel ShohamDepartment of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Arturo CasadevallW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Nichol A McBeeDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Daniel AmiraultDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0003-3938-7671
Ying WangYale Center for Clinical Investigation, Yale University School of Medicine, New Haven, CT, USA.
Erica HopkinsAerotek, Hanover, MD, USA.
David M ShadeDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Oliver LayendeckerDivision of Intramural Research, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Sabra L KleinW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Han-Sol ParkW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
John S LeeW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Patrizio CaturegliDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Jay S RavalDepartment of Pathology, University of New Mexico School of Medicine, Albuquerque, NM, USA.
Daniel CruserNuvance Health Vassar Brothers Medical Center, Poughkeepsie, NY, USA.
Alyssa F ZimanDepartment of Pathology and Laboratory Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
Jonathan GerberDepartment 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 GniadekDepartment of Pathology and Laboratory Medicine, Endeavor Health, Evanston, IL, USA.
Evan M BlochDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Aaron A R TobianDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Daniel F HanleyDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-9536-4258
David J SullivanDepartment of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0003-0319-0578
Karen LaneDepartment of Neurology, BIOS Clinical Trial Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-7529-0714
CSSC (COVID 19 Serologic Studies Consortium) group

Funding

The University of Rochester's Clinical and Translational Science InstituteUL1TR002001 · NCATS · UNIVERSITY OF ROCHESTER · PI WILSON, KAREN M., ZAND, MARTIN S · 2016 to 2024
$34.6M
NCATS NIH HHS UL1 TR002001
6 · The paper itself

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.

Indexed as

clinical trial managementcloud-based platformconvalescent plasmaCOVID-19decentralized clinical trialinvestigational drug servicessupply chain management

Identifiers

PMID39655012
PMCPMC11626586

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.