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Whitaker, Barbee

https://orcid.org/0000-0002-6311-6268

Mayo Clinic

Center for Biologics Evaluation and Research

Citations 4

Early administration of COVID‐19 convalescent plasma with high titer antibody content by live viral neutralization assay is associated with modest clinical efficacy
Huang, Yin , Villa, Carlos H. , Whitaker, Barbee , Anderson, Steven A. , Verdun, Nicole, Joyner, Michael J. , Wright, Scott, Carter, Rickey E. , Hung, Deborah T. , Homer, Mary J. , Hoffman, Corey M., Lauer, Michael S. , Wright, Scott R, Marks, Peter , Carter, Rickey E , Joyner, Michael J , Belov, Artur , Forshee, Richard A. , Eder, Anne F. , Wright, Scott R.

American Journal of Hematology | March 18, 2022 | Volume: 97 | Issue: 6 | Pages: 770-779

10.1002/ajh.26531 Get It

AbstractThe efficacy of COVID‐19 convalescent plasma (CCP) as a treatment for hospitalized patients with COVID‐19 remains somewhat controversial; however, many studies have not evaluated CCP documented to have high neutralizing antibody titer by a highly accurate assay. To evaluate the correlation of the administration of CCP with titer determined by a live viral neutralization assay with 7‐ and 28‐day death rates during hospitalization, a total of 23 118 patients receiving a single unit of CCP were stratified into two groups: those receiving high titer CCP (>250 50% inhibitory dilution, ID50; n = 13 636) or low titer CCP (≤250 ID50; n = 9482). Multivariable Cox regression was performed to assess risk factors. Non‐intubated patients who were transfused with high titer CCP showed 1.1% and 1.7% absolute reductions in overall 7‐ and 28‐day death rates, respectively, compared to those non‐intubated patients receiving low titer CCP. No benefit of CCP was observed in intubated patients. The relative benefit of high titer CCP was confirmed in multivariable Cox regression. Administration of CCP with high titer antibody content determined by live viral neutralization assay to non‐intubated patients is associated with modest clinical efficacy. Although shown to be only of modest clinical benefit, CCP may play a role in the future should viral variants develop that are not neutralized by other available therapeutics.
Hemovigilance and the Notify Library
Whitaker, Barbee , Strong, Douglas M., Gandhi, Manish J. , Petrisli, Evangelia

Immunohematology | April 30, 2021 | Volume: 33 | Issue: 4 | Pages: 159-164

10.21307/immunohematology-2019-023 Get It

Abstract Hemovigilance systems allow reporting of adverse occurrences associated with blood transfusion to a central database where events can be reviewed and analyzed for the benefit of patients and donors. Hemolytic and serologic transfusion reactions are among the many types of reactions reported to these systems. The Notify Library, a database of adverse events associated with medical products of human origin, has incorporated hemovigilance into its didactic resources. Students and practitioners are encouraged to use the electronic library and to further enhance this resource through review and recommendation of additional publications in the area of immunohematology. Immunohematology 2017;33:159–164.
A brief overview of clinical significance of blood group antibodies
Strong, D.M., Whitaker, Barbee , Gandhi, Manish J. , Petrisli, Evangelia

Immunohematology | April 16, 2021 | Volume: 34 | Issue: 1 | Pages: 4-6

10.21307/immunohematology-2018-002 Get It

Abstract This review was derived from a presentation made on September 2, 2016 for the first Academy Day presented by the Working Party on Immunohematology at the International Society of Blood Transfusion (ISBT) Congress in Dubai. The focus of this review is to provide a brief overview of the clinical significance of blood group antibodies. Blood group antibodies can be naturally occurring (e.g., anti-A and anti-B through exposure to naturally occurring red blood cell [RBC] antigen-like substances) or can occur via exposure to foreign (donor) RBC antigens through previous transfusions, transplants, or exposure to fetal RBCs during or after pregnancy. However, not all blood group antibodies are clinically significant. Clinically significant blood group antibodies can cause adverse events after blood component transfusion or transplantation and/or can cause hemolytic disease of the fetus and newborn. Immunohematology 2018;34:4–6.
Impact of changes to donor hemoglobin criteria on the rate of donor deferral
Perez, Gabriela, Whitaker, Barbee , Vassallo, Ralph R. , Stubbs, James R. , Vassallo, Ralph R , Gammon, Richard R.

Transfusion | September 28, 2018 | Volume: 58 | Issue: 11 | Pages: 2581-2588

10.1111/trf.14950 Get It

BACKGROUND The Food and Drug Administration's requirements for “Blood and Blood Components Intended for Transfusion or Further Manufacturing Use” (Final Rule) effective May 2016 changed eligibility criteria for blood donors. A multivariate analysis was performed to measure its impact on donor deferral rates. STUDY DESIGN AND METHODS Four blood centers submitted data for similar 6‐month periods before and after implementation of the Final Rule. Data included presenting donors, units collected, deferrals, intended products from deferred donors, deferral reasons, presenting donor demographics, donor hemoglobin (Hgb), hematocrit (HCT), pulse, blood pressure (BP), temperature, and other reasons for deferral. Data were aggregated and periods compared. RESULTS After Final Rule implementation, successful donations decreased by 1.3% (83.1%‐81.9%), despite a 0.2% increase in presenting donors. The rate of Hgb/HCT, pulse, and deferrals increased, while deferrals for other reasons decreased. Male Hgb/HCT deferral rates increased 1.2% (4213 total). Black male donors' Hgb/HCT deferral rate increased (2.7%‐5.2%) but was counterbalanced by an overall 3.7% decrease in black female Hgb/HCT deferrals. While Hgb/HCT deferrals of black donors remained stable overall (17.0% vs. 16.2%), this trend was not observed by all centers. Deferrals for pulse increased (0.2%), as did BP deferrals (0.2%). CONCLUSION Although there was a small increase in presenting donors after implementation of the Final Rule, there was a decrease in successful donations. While it appeared that deferral in black donors was unchanged, this trend was not observed across all centers. Pulse and BP deferrals rose dissimilarly among centers, according to individual procedures.