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Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients: A Randomized Clinical Trial

Ortigoza, Mila B; Yoon, Hyunah; Goldfeld, Keith S; Troxel, Andrea B; Daily, Johanna P; Wu, Yinxiang; Li, Yi; Wu, Danni; Cobb, Gia F; Baptiste, Gillian; O'Keeffe, Mary; Corpuz, Marilou O; Ostrosky-Zeichner, Luis; Amin, Amee; Zacharioudakis, Ioannis M; Jayaweera, Dushyantha T; Wu, Yanyun; Philley, Julie V; Devine, Megan S; Desruisseaux, Mahalia S; Santin, Alessandro D; Anjan, Shweta; Mathew, Reeba; Patel, Bela; Nigo, Masayuki; Upadhyay, Rabi; Kupferman, Tania; Dentino, Andrew N; Nanchal, Rahul; Merlo, Christian A; Hager, David N; Chandran, Kartik; Lai, Jonathan R; Rivera, Johanna; Bikash, Chowdhury R; Lasso, Gorka; Hilbert, Timothy P; Paroder, Monika; Asencio, Andrea A; Liu, Mengling; Petkova, Eva; Bragat, Alexander; Shaker, Reza; McPherson, David D; Sacco, Ralph L; Keller, Marla J; Grudzen, Corita R; Hochman, Judith S; Pirofski, Liise-Anne; Parameswaran, Lalitha; Corcoran, Anthony T; Rohatgi, Abhinav; Wronska, Marta W; Wu, Xinyuan; Srinivasan, Ranjini; Deng, Fang-Ming; Filardo, Thomas D; Pendse, Jay; Blaser, Simone B; Whyte, Olga; Gallagher, Jacqueline M; Thomas, Ololade E; Ramos, Danibel; Sturm-Reganato, Caroline L; Fong, Charlotte C; Daus, Ivy M; Payoen, Arianne Gisselle; Chiofolo, Joseph T; Friedman, Mark T; Wu, Ding Wen; Jacobson, Jessica L; Schneider, Jeffrey G; Sarwar, Uzma N; Wang, Henry E; Huebinger, Ryan M; Dronavalli, Goutham; Bai, Yu; Grimes, Carolyn Z; Eldin, Karen W; Umana, Virginia E; Martin, Jessica G; Heath, Timothy R; Bello, Fatimah O; Ransford, Daru Lane; Laurent-Rolle, Maudry; Shenoi, Sheela V; Akide-Ndunge, Oscar Bate; Thapa, Bipin; Peterson, Jennifer L; Knauf, Kelly; Patel, Shivani U; Cheney, Laura L; Tormey, Christopher A; Hendrickson, Jeanne E
Importance/UNASSIGNED:There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19. Objective/UNASSIGNED:To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen. Design, Setting, and Participants/UNASSIGNED:CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021. The trial enrolled 941 participants who were hospitalized for 3 or less days or presented 7 or less days after symptom onset and required noninvasive oxygen supplementation. Interventions/UNASSIGNED:A unit of approximately 250 mL of CCP or equivalent volume of placebo (normal saline). Main Outcomes and Measures/UNASSIGNED:The primary outcome was participant scores on the 11-point World Health Organization (WHO) Ordinal Scale for Clinical Improvement on day 14 after randomization; the secondary outcome was WHO scores determined on day 28. Subgroups were analyzed with respect to age, baseline WHO score, concomitant medications, symptom duration, CCP SARS-CoV-2 titer, baseline SARS-CoV-2 serostatus, and enrollment quarter. Outcomes were analyzed using a bayesian proportional cumulative odds model. Efficacy of CCP was defined as a cumulative adjusted odds ratio (cOR) less than 1 and a clinically meaningful effect as cOR less than 0.8. Results/UNASSIGNED:Of 941 participants randomized (473 to placebo and 468 to CCP), 556 were men (59.1%); median age was 63 years (IQR, 52-73); 373 (39.6%) were Hispanic and 132 (14.0%) were non-Hispanic Black. The cOR for the primary outcome adjusted for site, baseline risk, WHO score, age, sex, and symptom duration was 0.94 (95% credible interval [CrI], 0.75-1.18) with posterior probability (P[cOR<1] = 72%); the cOR for the secondary adjusted outcome was 0.92 (95% CrI, 0.74-1.16; P[cOR<1] = 76%). Exploratory subgroup analyses suggested heterogeneity of treatment effect: at day 28, cORs were 0.72 (95% CrI, 0.46-1.13; P[cOR<1] = 93%) for participants enrolled in April-June 2020 and 0.65 (95% CrI, 0.41 to 1.02; P[cOR<1] = 97%) for those not receiving remdesivir and not receiving corticosteroids at randomization. Median CCP SARS-CoV-2 neutralizing titer used in April to June 2020 was 1:175 (IQR, 76-379). Any adverse events (excluding transfusion reactions) were reported for 39 (8.2%) placebo recipients and 44 (9.4%) CCP recipients (P = .57). Transfusion reactions occurred in 2 (0.4) placebo recipients and 8 (1.7) CCP recipients (P = .06). Conclusions and Relevance/UNASSIGNED:In this trial, CCP did not meet the prespecified primary and secondary outcomes for CCP efficacy. However, high-titer CCP may have benefited participants early in the pandemic when remdesivir and corticosteroids were not in use. Trial Registration/ Identifier: NCT04364737.
PMID: 34901997
ISSN: 2168-6114
CID: 5084962

B subgroup detection in a small hospital transfusion service [Case Report]

Elardo, E; Elbadri, N; Sanchez, C; Powell, V; Smaris, M; Li, Y; Jacobson, J; Hilbert, T; Hamilton, T; Wu, D W
The ABO blood group system includes phenotypes, or subgroups, that differ in the amount of A and B antigens present on the red blood cells (RBCs). These subgroups also differ in the A, B, or H substances present in secretions (for individuals who have the secretor phenotype). B subgroups are very rare and are less frequently reported than A subgroups. Usually, B subgroups are discovered during serologic testing when there is a discrepancy between RBC and serum grouping results. Subgroups of B are usually identified by a reference laboratory using molecular and adsorption-elution methods. This report details a case of a young, healthy, pregnant woman with a B subgroup detected by a small transfusion service using adsorption-elution methods. Serology and genotyping of the ABO gene was performed at a reference laboratory where the serology was consistent with a B subgroup, but no changes were identified in ABO gene sequencing. It is important to correctly identify B subgroups in donors and recipients to help resolve ABO discrepancies and potentially prevent ABO incompatibility in blood transfusion, thus minimizing transfusion reactions.
PMID: 34170644
ISSN: 0894-203x
CID: 4964882

Apheresis physician well-being during the COVID-19 pandemic: Results of a survey

Tanhehco, Yvette C; Li, Yanhua; Zantek, Nicole D; Becker, Joanne; Alsammak, Mohamed; Mikesell, Kael; Wu, Ding Wen; Foster, Tisha; Chhibber, Vishesh; Martin, Marisa Saint; Wehrli, Gay
BACKGROUND:The COVID-19 pandemic has placed additional stressors on physician lives. In this study, we report findings from a survey conducted among attending physician (AP) members of the American Society for Apheresis (ASFA) to elucidate the status of their well-being during the COVID-19 pandemic as well as resources provided or actions taken by their institutions and themselves personally to maintain or improve their well-being. STUDY DESIGN AND METHODS/METHODS:A 17-question, voluntary, IRB-approved survey regarding well-being was distributed to the ASFA AP members between August 26, 2020 and September 16, 2020. The descriptive analyses were reported as number and frequency of respondents for each question. Non-parametric chi-square tests, ANOVA, and paired t-tests were performed to determine differences in categorical variables, changes in well-being scores, and compare time points, respectively. RESULTS:Based on the responses of 70 attending level physicians representing the United States (U.S., 53, 75.7%) and outside the U.S. (17, 24.3%), the following were observed: (1) COVID-19 negatively affects the well-being of a sub-population of APs, (2) neither institutional nor individual measures to improve well-being completely resolved the problem of decreased AP well-being during the pandemic, and (3) personal actions may be superior to institutional resources. CONCLUSION/CONCLUSIONS:There is a widespread decline in AP well-being during the COVID-19 pandemic that was not adequately improved by institutional or personal resources/actions taken. Institutions and physicians must work together to implement strategies including resources and actions that could further improve AP physician well-being during a public health crisis.
PMID: 33619750
ISSN: 1537-2995
CID: 4808082

Therapeutic apheresis : a guide to billing and securing appropriate reimbursement

Hofmann, Jan C; Andrzejewski, Chester; Aqui, Nicole; Ipe, Tina S; Knight, Susan; Li, Yanhua; Linz, Walter; Ricci, Kristin; Roberts, Tim; Silver, Alicia; De Simone, Nicole; Stone, Leah M; Wu, Ding Wen
Vancouver BC : American Society for Aphereis, 2021
Extent: 34 p.
CID: 5103302

Apheresis medicine in the era of advanced telehealth technologies: An American Society for Apheresis position paper Part I: Understanding the basic technologies and apheresis medicine practice models

Linz, Walter; Andrzejewski, Chester; Wu, Ding Wen; Li, Yanhua; Roberts, Timothy; Ipe, Tina; Ricci, Kristin; Knight, Susan; Hodjat, Parsa; Reddy, Ramakrishna L; Hofmann, Jan
The wide spread availability and use of sophisticated high-speed telecommunication networks coupled with inexpensive and easily accessible computing capacity have catalyzed the creation of new tools and strategies for healthcare delivery. Such tools and strategies are of value to apheresis medicine (AM) practitioners if they improve delivery of patient care, enhance safety during a therapeutic apheresis (TA) intervention, facilitate care access, advance technical capabilities of apheresis devices, and/or elevate quality performance within TA programs. In the past several years, healthcare delivery systems' adoption of telecommunication technologies has been fostered by organizational financial and quality improvement objectives. More recently, adoption of telehealth technologies has been catalyzed by the COVID-19 pandemic as these technologies enhance both patient and provider safety in an era of social distancing. These changes will also influence the delivery of TA services which now can be generally viewed in a tripartite model format comprised of traditional hospital-based fixed site locales, mobile TA operations and lately an evolving telemedicine remote management model now reffered to as telapheresis (TLA). This communication developed by the Public Affairs and Advocacy Committee of the American Society for Apheresis (ASFA) and endorsed by its Board of Directors, reviews and describes various aspects of established and evolving electronic technologies related to TLA and the practice of AM. In subsequent companion publications, additional aspects to TLA will be explored and ASFA's vision of reasonable, regulatory compliant and high-quality TLA practices will be expounded.
PMID: 33470463
ISSN: 1098-1101
CID: 4762372

Therapeutic apheresis : a guide to billing and securing appropriate reimbursement

Hofmann, Jan C; Andrzejewski, Chester; Ipe, Tina S; Li, Yanhua; Linz, Walter; Reddy, Ramakrishna L; Roberts, Tim; Ricci, Kristin; Silver, Alicia; De Simone, Nicole; Stone, Leah M; Wu, Ding Wen
Vancouver BC : American Society for Aphereis, 2020
Extent: 34 p.
CID: 5103312

Vascular access practices for therapeutic apheresis: Results of a survey

Tanhehco, Yvette C; Zantek, Nicole D; Alsammak, Mohamed; Chhibber, Vishesh; Li, Yanhua; Becker, Joanne; Wu, Ding W; Foster, Tisha; Wehrli, Gay
INTRODUCTION/BACKGROUND:Obtaining vascular access (VA) is a critical part of the therapeutic apheresis (TA) treatment plan. Currently, there are no guidelines for VA decision-making and maintenance related to TA procedures. MATERIALS AND METHODS/METHODS:A 28-question survey to gather qualitative information regarding VA practices was distributed to the American Society for Apheresis (ASFA) 2018 Annual Meeting attendees and all ASFA members for voluntary participation. The descriptive analyses were reported as the number and frequency of responses for each question. RESULTS:Total participation was 206 with 147 (71.4%) answering some or all 16 VA focused questions. The majority of respondents were nurses or physicians (89.0%) at sites providing ≥100 procedures. The most common TA procedures were plasma exchange, red cell exchange, and leukocytapheresis. The VA evaluation was predominantly performed by the TA service (80.3%, 118/147). The majority of TA physicians and/or providers do not insert (91.7%, 132/144) or remove (81.2%, 117/143) VA catheters. When an emergent TA procedure is needed, the majority of respondents felt <2 hours was an acceptable turnaround time for VA placement (64.3%, 92/143). The most common anticoagulant for locking catheters and/or ports was heparin. The majority of TA services (54.3%, 76/140) collect data on aborted procedures due to catheter/line/port problems unrelated to infection, but only 41.4% (58/140) collect data on infections. CONCLUSION/CONCLUSIONS:VA contributes significantly to the overall risks associated with and the safety of TA. Our survey shows that there is substantial variation but common themes in TA VA practices. Several areas for future research may be identified.
PMID: 31268582
ISSN: 1098-1101
CID: 3968142

Patient blood management: Changing a culture with transfusion therapy at the right time for the right indication [Meeting Abstract]

Karpinos, R; Cobaj, V; Sender, J; Wu, D W
INTRODUCTION: An organized, evidence-based multidisciplinary approach to transforming blood transfusion practices may help limit usage of blood bank resources. A Patient Blood Management (PBM) program was initiated in 2013 and fully implemented in 2014 at our urban, 350-bed acute care center: broad-based educational modules for licensed practitioners, laboratory conversions to low-volume samples, changes in hemoglobin (Hgb) critical-level reporting and adjustment of divisional transfusion protocols and guidelines (e.g. universally decreasing transfusion triggers to Hgb 6g/dL standard in non-critical patients, with 7g/dL in the setting of known cardiac disease; and changing initial number of packed red blood cell [PRBC] transfusions to 1 unit instead of 2 units). The goal of this study is to analyze the effectiveness of this PBM program.
METHOD(S): We retrospectively analyzed transfusion data from January 1, 2012-December 31, 2018. Continuous variables were analyzed for Hgb on transfusion orders, number of PRBC units transfused, PRBC wastage and potential cost-savings. T-tests were used to analyze the data of this 7 years' study.
RESULT(S): Significant improvement in PRBC transfusion practices and usage occurred after implementation of the PBM program. Mean Hgb for PRBC transfusion orders decreased year-over-year after PBM program implementation compared to nadir 6.73 g/dL in 2018 vs 7.35 g/dL in 2012 (p<0.0001). Similarly, the absolute number and percentage of transfused PRBC units of the Hgb trigger >= 8g/dL significantly decreased year-over-year reaching a nadir in 2018 compared to 2012 (101 units vs 462 units, and 7.9% vs 24.7%, p<0.001). During the same period, wastage also profoundly reduced (3 units vs. 28 units). Potential cost-savings peaked at $216,048 in 2018 with total potential cost-savings of $950,915 during the 6-year PBM program implementation. Impressively the progress of this PBM program has been made on a $0 budget. DISCUSSION: An organized, evidence-based multidisciplinary PBM program may improve the culture of institutional PRBC transfusion practices and translate to more optimal patient care and resource utilization as well as pronounced cost-savings, as demonstrated in this study. Continual implementation of a PBM program may have cumulative effect. Continued education and further work needs to be done to maintain the current trends and expand the program into platelet and plasma therapy
ISSN: 1526-7598
CID: 4101922

Subgroup B detection in a small hospital transfusion service [Meeting Abstract]

Elardo, E; Sanchez, C; Powell, V; Smaris, M; Li, Y; Jacobson, J; Hilbert, T; Hamilton, T; Wu, D
Background: An ABO blood group subtype is called a subgroup and/or variant. Subgroups of ABO are often distinguished by decreased amounts of A, B or O (H) antigens on red blood cells. Blood type A appears to have the most variation in subgroups. In general, serologic distinction between A1 and other subgroups of A is based on the ability of anti- A1 lectin (an extract of Dolichos biflorus seeds) to agglutinate A1 red blood cells (RBC) but not cells of other A subgroups. As A2 is most common A subtype and is frequently detected at regular hospital transfusion services. Definitive identification of ABO subgroups is usually performed at a reference laboratory using molecular techniques and special immunohematology methods. Here we report an interesting case where a subgroup B was detected by an astute technologist using manual immunohematology tests and conventional reagents at our hospital transfusion service. Our hospital transfusion service received a blood specimen requesting a type and screen from a pregnant woman with no known medical problems. Testing the specimen showed a front type of O and a back type of B, with a negative antibody screening.
Aim(s): To resolve the typing discrepancy and to correctly Identify the ABO blood type of the pregnant patient.
Method(s): In an attempt to enhance the typing reactions with the patient's RBCs and plasma, mixtures of the front typing and back typing were incubated separately for 15 minutes at room temperature. This however did not result in any change in reactivity. The technologist became suspicious of a possible B subgroup as this was a healthy young woman and it would be rare for such a young patient to exhibit missing antibodies in the reverse type. He then performed a DAT on the specimen to assure that nothing was coating the patient's RBCs which might interfere with further testing. The DAT was negative for IgG and C3d. He subsequently performed an absorption on vigorously washed patient RBC) with anti-B reagent from Ortho. The reaction mixture was incubated at room temperature (RT) for 15 minutes, followed by an elution. The eluate was added to washed A cells, B cells, and screening cells (Ortho), and then incubated at room temperature for 15 minutes. The mixtures were washed with eluate washing solution. Anti-IgG Coombs reagent was added, the tubes were centrifuged, and results were recorded.
Result(s): A cells: Negative B cells: 2 + Screen cell #1: negative Screen cell #2: negative Screen cell #3: negative Summary/Conclusions: Based on the manual tests the technologist designed and performed, he was able to demonstrate the 2 + reactivity with type B reagent RBCs and concluded that the patient's blood type is a B subgroup. The patient's specimen was then sent to New York Blood Center Immunohematology Reference Laboratory for further confirmation and identification. The B group of the patient's RBCs was not detectable again by the conventional immunohematology tests. Molecular tests (PCR-RFLP) and full gene sequencing were performed. A B allele (*B1.01) and an O1 allele (*O1.09) were identified, which predicts a B weak subtype. The molecular testing confirms the conclusion made by our technologist using conventional manual immunohematology tests
ISSN: 1423-0410
CID: 4784112

Therapeutic apheresis : a guide to billing and securing appropriate reimbursement

Hofmann, Jan C; Andrzejewski, Chester; Adamski, Jill; Ipe, Tina S; Li, Yanhua; Linz, Walter; Reddy, Ramakrishna L; Roberts, Tim; Ricci, Kristin; Silver, Alicia; De Simone, Nicole; Stone, Leah M; Wu, Ding Wen
Vancouver BC : American Society for Aphereis, 2019
Extent: 34 p.
CID: 5103322