The bioequivalence of frozen plasma prepared from whole blood held overnight at room temperature compared to fresh‐frozen plasma prepared within eight hours of collection

Dumont, Larry J.; Cancelas, José A.; Maes, Lou Ann; Rugg, Neeta; Whitley, Pamela; Herschel, Louise; Siegel, Alan; Szczepiórkowski, Zbigniew M.; Hess, John R.; Zia, Majid

doi:10.1111/trf.12864

Cited by 14 publications

(20 citation statements)

References 13 publications

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“…van der Meer and de Korte also reported no effect of active cooling of whole blood held overnight on FVIII activity in generated plasma [61]. These results on holding effects have in general been replicated by investigators using different whole blood processing methods and different anticoagulants in different nations and transfusion services [36, 62–66]. There is no evidence that the declines in coagulation factor activity associated with holding effects compromise clinical efficacy, and therefore economic and strategic considerations have prompted greater use of FP-type plasmas over FFP [42, 67].…”

Section: Overview: Assessing the Quality Of Transfusable Plasmamentioning

confidence: 90%

Quality Assessment of Established and Emerging Blood Components for Transfusion

Acker

Marks

Sheffield

2016

Journal of Blood Transfusion

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Blood is donated either as whole blood, with subsequent component processing, or through the use of apheresis devices that extract one or more components and return the rest of the donation to the donor. Blood component therapy supplanted whole blood transfusion in industrialized countries in the middle of the twentieth century and remains the standard of care for the majority of patients receiving a transfusion. Traditionally, blood has been processed into three main blood products: red blood cell concentrates; platelet concentrates; and transfusable plasma. Ensuring that these products are of high quality and that they deliver their intended benefits to patients throughout their shelf-life is a complex task. Further complexity has been added with the development of products stored under nonstandard conditions or subjected to additional manufacturing steps (e.g., cryopreserved platelets, irradiated red cells, and lyophilized plasma). Here we review established and emerging methodologies for assessing blood product quality and address controversies and uncertainties in this thriving and active field of investigation.

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Section: Overview: Assessing the Quality Of Transfusable Plasmamentioning

confidence: 90%

Quality Assessment of Established and Emerging Blood Components for Transfusion

Acker

Marks

Sheffield

2016

Journal of Blood Transfusion

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“…However, the data reported here from the current design that were driven by regulatory demands for product approval support overnight hold of whole blood at room temperature with subsequent storage of the RBCs in AS‐7 for up to 42 days. Consideration of the bioequivalence of plasma prepared from room temperature, overnight held whole blood is presented in an accompanying article . The combination of overnight hold with AS‐7 storage of RBCs should offer important safety, logistic, and cost benefits to the blood supplier and patient.…”

Section: Discussionmentioning

confidence: 99%

“…All test RBCs were placed in AS‐7. Analytical methods, plasma results, and data from the control, 2‐hour, and 8‐hour groups are described in the companion articles . Each center conducted all assays within their own institution.…”

Section: Methodsmentioning

confidence: 99%

Overnight, room temperature hold of whole blood followed by 42‐day storage of red blood cells in additive solution‐7

et al. 2014

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BACKGROUND:Overnight, room temperature hold (ONH) of whole blood before component processing offers several benefits. This study evaluated the storage and in vivo recovery characteristics of ONH red blood cells (RBCs) stored in additive solution-7 (AS-7). STUDY DESIGN AND METHODS:We conducted a three-center, three-arm evaluation of a new blood collection system with AS-7 compared to leukoreduced RBCs processed within 8 hours and stored in AS-1 (control). Whole blood (500 ± 50 mL) from healthy research subjects (n = 240) was held at room temperature 0 to 2 hours, 6 to 8 hours, or ONH (18-24 hr) before component processing and storage at 1 to 6°C. RBCs were evaluated on Days 42 and 56 with a panel of in vitro assays. Subsets of the AS-7-stored RBCs were evaluated for 51 Cr 24-hour in vivo recovery and long-term survival. RESULTS: Adenosine triphosphate (ATP) levels in ONH RBCs were not different than AS-7 RBCs prepared within 8 hours. ATP was higher in the ONH group on Day 42 than control, and ATP was maintained in all AS-7 groups through Day 56. ONH units had 0.36 ± 0.14% on Day 42 hemolysis (60/60 < 0.8%), and 0.54 ± 0.22% on Day 56 (10/60 > 0.8%, 2/60 > 1%). In vivo recoveries of stored RBCs were not different between the AS-7 arms at 42 days (p = 0.16; 27/27 ONH units > 75%), but the Day 56 ONH was significantly less than ONH on Day 42 (p = 0.008; 7/28 < 75%). CONCLUSIONS: Overnight hold of whole blood at room temperature before component processing meets current regulatory requirements when RBCs are stored up to 42 days in AS-7.

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“…Drs Greenwalt and Hess invented an anticoagulant‐preservative solution with additional phosphate and bicarbonate, AS‐7, that increases the pH of currently licensed adenine, glucose, and mannitol containing ASs. Articles by Cancelas and colleagues and Dumont and colleagues, in this issue of TRANSFUSION , demonstrate the biochemical and clinical characteristics of leukoreduced RBCs stored for 42 and 56 days and plasma prepared from whole blood stored under current conditions or subjected to ONH and nonrefrigerated conditions before component preparation. By recognizing the importance of coordinating pH and metabolic rates at reduced temperature, this process demonstrates improved biochemical status, lessened hemolysis, and greater RBC recovery in AS‐7–stored, leukoreduced RBCs after 56‐day storage compared to currently approved systems (AS‐1) at 42 days.…”

mentioning

confidence: 99%

“…Additionally, Dumont and coworkers report on plasma prepared from whole blood units subjected to ONH at room temperature that was frozen and stored for 1 year. In the absence of defined criteria for frozen plasma, other than FVIII levels, Dumont and colleagues sought to demonstrate bioequivalence (levels 80%‐125% of control) of plasma obtained from whole blood and held at room temperature for 24 hours (PF24RT24WB) before leukoreduction by filtration with their findings of plasma frozen within 8 hours of collection (FFP). They used a non–FDA‐approved filter for these experiments, which may have significance in light of a recent report that leukoreduction is more important than hold time for plasma coagulant properties .…”

mentioning

confidence: 99%

Is longer better?

Menitove¹

2015

Transfusion

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Is longer better?D uring the past 100 years, a greater understanding of the red blood cell (RBC) "storage lesion" and resultant improvements in anticoagulant-preservative solutions and storage containers incrementally improved the ex vivo quality and storage duration of stored blood and blood components. Citrate and glucose solutions followed by acidified citrate dextrose (ACD) solutions, less acidified ones incorporating citrate-phosphate-dextrose (CPD), and those with adenine (CPDA-1) that increase ATP levels extended the shelf life of whole blood and RBC components from 14 to 35 days. Subsequently, additive solutions (ASs) applied only to RBCs lengthened storage to 49 days, later reduced to 42 days because of concerns about inadequate RBC recoveries. Interestingly, Dumont and colleagues 1 note in this issue of TRANSFUSION that there are no published studies of in vivo RBC recoveries in healthy subjects receiving RBCs stored for 6 weeks in AS-1. Moroff and others eventually reported a 76.0 ± 5.4% 24-hour recovery of 42-day-stored, nonleukoreduced RBCs and a 79.2 ± 4.3% recovery after 35 days of storage. Importantly, these RBCs were prepared from whole blood maintained for 7 hours on 20 to 24°C "temperature stabilizing packages," butane-1,4-diol plates, before AS-1 addition, refrigeration, and storage. Presumably, the 49-day storage interval would not meet current Food and Drug Administration (FDA) standards of "mean 24-hour, post transfusion, in vivo red cell recovery at end of storage of at least 75% with a standard deviation of at most 9% and lower limit of a one sided 95% confidence interval for the population proportion of successes is 70% or greater."Recent evaluations of the "storage lesion" cast additional doubt about prolonged ex vivo RBC storage. The growing database demonstrates losses of RBC ATP and 2,3-DPG levels, membrane-protectant sugars, RBC deformity and concave shape with resultant increases in hemolysis, microvesicle shedding, iron release and associated nitric oxide scavenging or infection risk, echinocyte formation, and release of cytokines and procoagulants.Concomitantly, new information and logistic and economic considerations sparked interest in increasing the interval and modifying the temperature requirements of whole blood between collection and component processing (manufacturing). Specifically, an overnight hold (ONH) with flexibility regarding temperature requirements could eliminate some pick-ups at distant blood drives needed currently for transporting whole blood to component laboratories for platelet (PLT) and frozen plasma preparation within the 8 hours required by FDA regulations. Component preparation during a single shift on the day after collection could replace costly two or three shift manufacturing operations now in place. Other potential advantages include greater male plasma inventories for transfusion-related acute lung injury mitigation and longer contact of white blood cells (WBCs) promoting autosterilization. ONH potentially increases PLT yields and eliminates th...

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The bioequivalence of frozen plasma prepared from whole blood held overnight at room temperature compared to fresh‐frozen plasma prepared within eight hours of collection

Cited by 14 publications

References 13 publications

Quality Assessment of Established and Emerging Blood Components for Transfusion

Quality Assessment of Established and Emerging Blood Components for Transfusion

Overnight, room temperature hold of whole blood followed by 42‐day storage of red blood cells in additive solution‐7

Is longer better?

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