Prion reduction of red blood cells: impact on component quality

Wiltshire, Michael; Thomas, Stephen; Scott, Janet; Hicks, Vicky; Haines, Martin; Cookson, Phil; Garwood, Margaret; Cardigan, Rebecca

doi:10.1111/j.1537-2995.2009.02500.x

Cited by 18 publications

(31 citation statements)

References 39 publications

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“…Quality management data collected at three time points during the study period showed that the mean volume and Hb of prion filtered and standard RCC were comparable and were above the minimum UKBTS specification (National Blood Service, 2005;Wiltshire et al, 2010). This suggests that prion filtration for selected patient groups could be implemented without compromising the Hb content of the component.…”

Section: Discussionmentioning

confidence: 87%

“…The prion filtration process results in reduced Hb levels due to red cell trapping within the filter (Wiltshire et al, 2010) and further dilution of the product with SAG-M to make the volume up to standard requirements (National Blood Service, 2005), therefore high volume units were selected for manufacture of the prion-filtered units transfused in this study. Quality management data collected at three time points during the study period showed that the mean volume and Hb of prion filtered and standard RCC were comparable and were above the minimum UKBTS specification (National Blood Service, 2005;Wiltshire et al, 2010).…”

Section: Discussionmentioning

confidence: 99%

“…Volume and Hb were recorded for all PF-RCC as the filter is known to retain red cells resulting in lower Hb levels (Wiltshire et al, 2010). Selection of larger units for filtration kept the final volume and Hb values within UKBTS requirements.…”

Section: Transfused Product Characteristicsmentioning

confidence: 99%

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Transfusion of prion‐filtered red cells does not increase the rate of alloimmunization or transfusion reactions in patients: results of the UK trial of prion‐filtered versus standard red cells in surgical patients (PRISM A)

et al. 2013

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SummaryThis study, conducted for the UK Blood Transfusion Services (UKBTS), evaluated the clinical safety of red cells filtered through a CE-marked prion removal filter (P-Capt). Patients requiring blood transfusion for elective procedures in nine UK hospitals were entered into a non-randomized open trial to assess development of red cell antibodies to standard red cell (RCC) or prion-filtered red cell concentrates (PF-RCC) at eight weeks and six months post-transfusion. Patients who received at least 1 unit of PF-RCC were compared with a control cohort given RCC only. About 917 PF-RCC and 1336 RCC units were transfused into 299 and 291 patients respectively. Twenty-six new red cell antibodies were detected post-transfusion in 10 patients in each arm, an overall alloimmunization rate of 4Á4%. Neither the treatment arm [odds ratio (OR) 0Á93, 95% confidence interval (CI) 0Á3, 2Á5] nor number of units transfused (OR 0Á95, 95% CI 0Á8, 1Á1) had a significant effect on the proportion of patients who developed new alloantibodies. No pan-reactive antibodies or antibodies specifically against PF-RCC were detected. There was no difference in transfusion reactions between arms, and no novel transfusion-related adverse events clearly attributable to PF-RCC were seen. These data suggest that prion filtration of red cells does not reduce overall transfusion safety. This finding requires confirmation in large populations of transfused patients.

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Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

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Transfusion of prion‐filtered red cells does not increase the rate of alloimmunization or transfusion reactions in patients: results of the UK trial of prion‐filtered versus standard red cells in surgical patients (PRISM A)

et al. 2013

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“…Meanwhile, as the number of reported cases of vCJD declines, manufacturers are losing interest in developing tests. Several filters have been developed that do remove prions along with WBCs, but thus far they appear be only moderately effective (1‐2 logs of reduction) and result in significant loss of RBC and changes to the resulting component 118 . There are no available techniques to inactivate prions in blood components.…”

Section: Creutzfeldt‐jacob Diseasementioning

confidence: 99%

Transfusion‐associated infections: 50 years of relentless challenges and remarkable progress

2010

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T he possibility of transfusion-transmitted infections has been a worry from the beginning of the modern era of blood banks. Beginning with the evidence that syphilis could be transmitted by blood transfusion and followed by increasing concerns about hepatitis, alarm peaked in the 1980s with the recognition of transfusion-associated AIDS and appreciation of the magnitude of transfusion transmission of hepatitis C virus (HCV). In more recent years the story has been one of remarkable successes in reducing transmission of known viral agents and rapid responses to emerging infectious diseases that are documented to be transmitted by blood transfusion.This review will address the response of the blood banking community to the major transfusion-transmitted infectious diseases (TTIDs) over the past 50 years, during which time the evolving appreciation of risk and progress in addressing TTIDs has been documented by more than 1000 publications in TRANSFUSION. Figure 1, which presents the annual number of publications in the journal focused on TTIDs relative to total publications, serves to demonstrate the increasing importance of TTIDs to the transfusion medicine community. It is evident that papers on TTIDs grew from a handful of papers per year that represented a minor proportion of the journal's publications to more than 50 papers per year representing 25% of articles appearing in TRANSFUSION in the 1980s and 1990s. The papers represented in the figure chronicle the remarkable contributions of several generations of scientists who not only aggressively addressed blood safety concerns but also advanced our understanding of methods of detection, natural history, and pathogenesis of TTIDs through studies of infected donors and recipients. SYPHILISThe evidence that syphilis can be transmitted by blood transfusion is unequivocal, with 138 cases published before 1941. 1 Blood donors were tested for syphilis long before blood banks became common. 2 In the early years of blood banking serologic tests for syphilis employed the nonspecific assay for antibodies to cardiolipin, usually using the VDRL or RPR versions of the original Wasserman test. In recent years automated assays have been developed that test for specific treponemal antibody, and almost all blood banks use that approach. In the initial switch from cardiolipin tests to tests with treponemal antibody, the rate of positive screening tests rose sharply, ABBREVIATIONS: BSE = bovine spongiform encephalopathy; IFA = indirect immunofluorescence assay; IND = investigational new drug; NANB = non-A, non-B; PRT(s) = pathogen reduction technology(-ies); PTH = posttransfusion hepatitis; PTLV(s) = primate T-lymphotropic virus(-es); TTID(s) = transfusiontransmitted infectious disease(s); TTV = transfusion-transmitted virus; vCJD = variant Creutzfeldt-Jacob disease; WNV = West Nile virus. Number of publications in TRANSFUSION, by year, focused on TTIDs (solid bars) relative to total publications (open bars), demonstrating the increasing importance of TTIDs to the transfusion medi...

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“…The resin also demonstrated the ability to remove endogenous infectivity from hamster leukoreduced RBCs to below the limit of detection of the bioassay used to determine the infectivity titer 11 . RBC storage variables after leukoreduced RBCs were filtered with the P‐Capt prion filter and then stored with either plasma‐CPD or SAGM to outdate have been evaluated 16‐18 . All of the final variables (hemoglobin [Hb] g/unit, hematocrit [Hct], residual WBCs, total volume) as well as end of shelf life product variables (hemolysis, adenosine 5′‐triphosphate [ATP], 2,3‐diphosphoglycerate acid [2,3‐DPG], potassium, and pH) were within the UK and Council of Europe Guidelines 19,20 .…”

mentioning

confidence: 99%

Infusion of P‐Capt prion‐filtered red blood cell products demonstrate acceptable in vivo viability and no evidence of neoantigen formation

Cancelas¹,

Rugg²,

Pratt³

et al. 2011

Transfusion

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Prion reduction of red blood cells: impact on component quality

Abstract: Prion filtration does not appear to have a detrimental effect on basic in vitro measures of RBC quality or on blood group antigens as assessed by in vitro methods. However, prion filtration using the P-Capt filter results in loss of Hb.

Cited by 18 publications

References 39 publications

Transfusion of prion‐filtered red cells does not increase the rate of alloimmunization or transfusion reactions in patients: results of the UK trial of prion‐filtered versus standard red cells in surgical patients (PRISM A)

Transfusion of prion‐filtered red cells does not increase the rate of alloimmunization or transfusion reactions in patients: results of the UK trial of prion‐filtered versus standard red cells in surgical patients (PRISM A)

Transfusion‐associated infections: 50 years of relentless challenges and remarkable progress

Infusion of P‐Capt prion‐filtered red blood cell products demonstrate acceptable in vivo viability and no evidence of neoantigen formation

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