Evaluation of two viral inactivation methods for the preparation of safer factor VIII and factor IX concentrates.

Abstract:

:We report here the results of our evaluation of two procedures to eliminate viruses in factor VIII and factor IX coagulation factor concentrates. Both procedures were equally effective in the in vitro destruction of marker viruses. However, in a controlled infectivity test in chimpanzees, treatment at 60 degrees C for 20 hours inactivated greater than 500 and less than 10,000 chimpanzee infectious doses (CID) of hepatitis B virus, while treatment at 98 degrees C for 30 minutes inactivated less than 500 CID. Both methods were successful in preventing infection with an undetermined amount of an indeterminate non-A, non-B hepatitis agent. The 60 degrees C, 20-hour treatment method rendered 5.25 logs of the putative acquired immune deficiency syndrome virus, human T-cell lymphotrophic virus III/lymphadenopathy virus, added to factor VIII or factor IX concentrates, undetectable. Heat-treated factor VIII and factor IX complex concentrates prepared by these methods were tested against corresponding untreated control lots. There was no significant difference in the plasma recovery or plasma half-life of the factor (p greater than 0.05). The treated concentrates were equivalent to the control concentrates with respect to vital signs, clinical laboratory studies, and adverse reactions. The heat-treated concentrates appeared bioequivalent to the untreated concentrates with the additional benefit of inactivation of potentially present infectious viruses.

journal_name

Transfusion

journal_title

Transfusion

authors

Heldebrant CM,Gomperts ED,Kasper CK,McDougal JS,Friedman AE,Hwang DS,Muchmore E,Jordan S,Miller R,Sergis-Davenport E

doi

10.1046/j.1537-2995.1985.25686071421.x

subject

Has Abstract,Author List Incomplete

pub_date

1985-11-01 00:00:00

pages

510-5

issue

6

eissn

0041-1132

issn

1537-2995

journal_volume

25

pub_type

临床试验,杂志文章
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    abstract:BACKGROUND:Although P1 and Xga are known to be associated with the A4GALT and XG genes, respectively, the genetic basis of antigen expression has been elusive. Recent reports link both P1 and Xga expression with nucleotide changes in the promotor regions and with antigen-negative phenotypes due to disruption of transcr...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.15089

    authors: Lane WJ,Aguad M,Smeland-Wagman R,Vege S,Mah HH,Joseph A,Blout CL,Nguyen TT,Lebo MS,Sidhu M,Lomas-Francis C,Kaufman RM,Green RC,Westhoff CM,MedSeq Project.

    更新日期:2019-03-01 00:00:00

  • A randomized trial of solvent/detergent-treated and standard fresh-frozen plasma in the coagulopathy of liver disease and liver transplantation.

    abstract:BACKGROUND:Virus inactivation of pooled fresh-frozen plasma (FFP) by the solvent/detergent (SD) method results in a loss of approximately 20 percent of factor VIII. This study aimed to assess the efficacy of SD-treated plasma in correcting the coagulopathy associated with liver disease and liver transplantation. STUDY...

    journal_title:Transfusion

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1046/j.1537-2995.1999.39111227.x

    authors: Williamson LM,Llewelyn CA,Fisher NC,Allain JP,Bellamy MC,Baglin TP,Freeman J,Klinck JR,Ala FA,Smith N,Neuberger J,Wreghitt TG

    更新日期:1999-11-01 00:00:00

  • Liquid storage of marrow stromal cells.

    abstract:BACKGROUND:Marrow stromal cells (MSCs) for clinical trials are inevitably stored before administration, but little is known about the effects of storage on MSCs. The effects of short-term liquid storage on the in vitro function of MSCs intended for a clinical trial were studied. STUDY DESIGN AND METHODS:Early-passage ...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2009.02138.x

    authors: Lane TA,Garls D,Mackintosh E,Kohli S,Cramer SC

    更新日期:2009-07-01 00:00:00

  • Comparison of the analytical and operational performance of two viral nucleic acid test blood screening systems: Procleix Tigris and cobas s 201.

    abstract:BACKGROUND:The operational and analytical performance of two automated triplex hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) nucleic acid test (NAT) systems were compared in four screening laboratories of the French Blood Service. STUDY DESIGN AND METHODS:Two laboratories eva...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2008.01965.x

    authors: Assal A,Barlet V,Deschaseaux M,Dupont I,Gallian P,Guitton C,Morel P,David B,De Micco P

    更新日期:2009-02-01 00:00:00

  • Duration of platelet storage and outcomes of critically ill patients.

    abstract:BACKGROUND:The storage duration of platelet (PLT) units is limited to 5 to 7 days. This study investigates whether PLT storage duration is associated with patient outcomes in critically ill patients. STUDY DESIGN AND METHODS:This study was a retrospective analysis of critically ill patients admitted to the intensive c...

    journal_title:Transfusion

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1111/trf.14056

    authors: Flint A,Aubron C,Bailey M,Bellomo R,Pilcher D,Cheng AC,Hegarty C,Reade MC,McQuilten Z

    更新日期:2017-03-01 00:00:00

  • NBTS/BRIC 8. A monoclonal anti-C3d antibody.

    abstract::A stable mouse hybridoma line secreting monoclonal anti-C3d antibody (NBTS/BRIC 8) was produced. Ascitic fluid containing BRIC 8 can be used at a final dilution of 1 to 5000 to provide an excellent antiglobulin reagent when mixed with a conventional polyclonal rabbit anti-human IgG serum. ...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1985.25385219912.x

    authors: Holt PD,Donaldson C,Judson PA,Johnson P,Parsons SF,Anstee DJ

    更新日期:1985-05-01 00:00:00

  • Platelet preservation. IV. Preparation and cryopreservation of platelet concentrates from fresh and overnight-stored human blood.

    abstract::Two methods were used for the preparation of platelet concentrates from fresh and overnight-stored human ACD blood. In a two-step method prostoglandin E1 was added to platelet rich plasma and the mixture was centrifuged to obtain platelet concentrate. The IBM 2991 Blood Cell Processor was used in a one-step method. Th...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1978.18178118562.x

    authors: Odink J,de Wit JJ,Janssen CL,Prins HK

    更新日期:1978-01-01 00:00:00

  • Identification of new KLF1 and LU alleles during the resolution of Lutheran typing discrepancies.

    abstract:BACKGROUND:The Lu(b) antigen is expressed on red blood cells (RBCs) of the majority of individuals in all populations. Its absence in transfused patients may lead to alloantibody production and mild-to-moderate transfusion reactions, and in pregnancies to mild hemolytic disease of the fetus and newborn. This report des...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.13556

    authors: Garcia-Sanchez F,Pardi C,Kupatawintu P,Thornton N,Rodriguez MA,Lucea I,Sood C,Ochoa-Garay G

    更新日期:2016-06-01 00:00:00

  • An evaluation of several blood transfusion filters.

    abstract::Several blood transfusion filters designed to remove microemboli were evaluated for filtration and flow characteristics, as well as for hemolysis and for release of particulate debris from the filter. The Dacron wool filter, a depth filter, was superior at removing microemboli measured with an electronic particle size...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1977.17678075651.x

    authors: Kennedy PS,Solis RT,Scott MA,Wilson RK

    更新日期:1977-11-01 00:00:00

  • Etoricoxib-induced immune hemolytic anemia: first case presenting acute kidney failure.

    abstract:BACKGROUND:Etoricoxib is a selective inhibitor of cyclooxygenase 2 used mainly to treat osteoarticular pain. Here, we report the case of a patient who developed acute kidney failure and immune hemolytic anemia after the use of etoricoxib. STUDY DESIGN AND METHODS:An 83-year-old female patient developed immune hemolyti...

    journal_title:Transfusion

    pub_type:

    doi:10.1111/trf.15226

    authors: Burgos Pratx L,Santoro D,Coca Mogro B,Valiente VL,Camino P,Scordo W,Salamone H

    更新日期:2019-05-01 00:00:00

  • Platelet crossmatches of single-donor platelet concentrates using a latex agglutination assay.

    abstract::A latex agglutination assay was evaluated for the purpose of identifying compatible platelet donors for alloimmunized recipients. Assay reagents were prepared by adsorbing detergent-solubilized, donor-specific platelets to polystyrene latex beads. Semiquantitative results for up to 30 donors can be completed in less t...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1993.33893342745.x

    authors: Ogden DM,Asfour A,Koller C,Lichtiger B

    更新日期:1993-08-01 00:00:00

  • Microbial challenge of a blood cell separator outside-seal bowl system.

    abstract::The ability to store platelets beyond 24 hours requires a functionally closed system. This study tested the ability of a cell separator bowl seal system to resist penetration of microbial contamination under normal running conditions and under extreme environmental stress. Three test organisms, Micrococcus luteus, Ser...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1990.30290162901.x

    authors: Jacobson MS,Kevy SV,Thorne GM,Goldmann DA,Blasetti L,Smith JW,Schaefer H

    更新日期:1990-02-01 00:00:00

  • Uneventful administration of plasma products in a recipient with T-activated red cells.

    abstract::A patient with T-polyagglutinable red cells and a severe coagulopathy provided an opportunity to observe the results of plasma transfusion in the face of T-activation. The patient was a 52-year-old Navajo Indian with a perforated gall bladder and related sepsis due to Clostridium perfringens. The gall bladder was remo...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1986.26286152912.x

    authors: Eversole M,Nonemaker B,Zurek K,South S,Simon T

    更新日期:1986-03-01 00:00:00

  • A multicenter evaluation of reproducibility of swirling in platelet concentrates. Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion.

    abstract:BACKGROUND:Eleven laboratories participated in a study investigating whether swirling can be used in monitoring platelet discoid morphology in platelet concentrates (PCs). STUDY DESIGN AND METHODS:In each laboratory, two readers observed the swirling pattern in 1- to 5-day-old PCs, in PCs containing spherical platelet...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1994.34994378282.x

    authors: Bertolini F,Murphy S

    更新日期:1994-09-01 00:00:00

  • Human herpesvirus 8 transfusion transmission in Ghana, an endemic region of West Africa.

    abstract:BACKGROUND:Human herpesvirus 8 (HHV-8) seroprevalence ranges between less than 5% in Europe and North America and 50% to 70% in sub-Saharan Africa. Evidence of HHV-8 transfusion transmission is only indirect. We conducted a serologic (anti-HHV-8) and molecular (HHV-8 DNA) study of samples from paired donor-immunocompet...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2012.03607.x

    authors: Gobbini F,Owusu-Ofori S,Marcelin AG,Candotti D,Allain JP

    更新日期:2012-11-01 00:00:00

  • Interactions of IgM ABO antibodies and complement with methoxy-PEG-modified human RBCs.

    abstract:BACKGROUND:RBCs modified with cyanuric chloride activated methoxy-PEG (CmPEG; 5000 Da) are less immunogenic than untreated RBCs, and their use thus may reduce the risk of alloimmunization in chronically transfused patients. STUDY DESIGN AND METHODS:To further examine the potential utility of CmPEG-RBCs, the effects of...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.2001.41101225.x

    authors: Bradley AJ,Test ST,Murad KL,Mitsuyoshi J,Scott MD

    更新日期:2001-10-01 00:00:00

  • Analysis of apheresis content of progenitor cell collections from normal donors to whom granulocyte-colony-stimulating factor is administered.

    abstract:BACKGROUND:Allogeneic blood cell transplantation is a new alternative to bone marrow transplantation. Preliminary data suggest that granulocyte-colony-stimulating factor (G-CSF)-mobilized peripheral blood progenitor cells from normal donors can provide rapid hematopoietic engraftment without significant increases in tr...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1996.36111297091734.x

    authors: Weinthal JA,Nemunaitis JJ,Aston S,Magsamen MJ,Rosenfeld CS

    更新日期:1996-11-01 00:00:00

  • Methicillin-resistant Staphylococcus aureus sepsis associated with the transfusion of contaminated platelets: a case report.

    abstract:BACKGROUND:Platelet transfusion-associated sepsis is usually due to donor skin flora introduced into the unit during phlebotomy. An unusual case of a platelet component contaminated with methicillin-resistant Staphylococcus aureus (MRSA) is reported. CASE REPORT:A 54-year-old man, terminally ill with progressive non-H...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.2001.41111426.x

    authors: Sapatnekar S,Wood EM,Miller JP,Jacobs MR,Arduino MJ,McAllister SK,Kellum ME,Roth V,Yomtovian R

    更新日期:2001-11-01 00:00:00

  • Determination of thromboelastographic responsiveness in stored single-donor platelet concentrates.

    abstract:BACKGROUND:Thromboelastography (TEG) is widely used in hospitals but less commonly in blood banks for evaluation of platelet (PLT) concentrates (PCs). A TEG-PC assay for testing fresh or stored PLTs must reflect the quality of the PLTs. The added value could be measurement of donor-dependent PLT quality. STUDY DESIGN ...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.12515

    authors: Bontekoe IJ,van der Meer PF,de Korte D

    更新日期:2014-06-01 00:00:00

  • In vitro safety profile of G-CSF-mobilized whole blood after storage for 7 days in an infusable-grade L15 medium.

    abstract:BACKGROUND:G-CSF-mobilized whole blood (WB) is a cost-reducing and simple alternative for peripheral blood progenitor cell transplantation. Recently, it was demonstrated that mobilized WB supplemented with Leibovitz's L15 medium permitted prolonged preservation of clonogenic cells at ambient temperature. In this study,...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1525-1438.2002.00064.x

    authors: de Kreuk AM,Jonkhoff AR,Zevenbergen A,Wilhelm AJ,van Oostveen JW,Schuurhuis GJ,Huijgens PC

    更新日期:2002-04-01 00:00:00

  • Factors affecting umbilical cord blood stem cell suitability for transplantation in an in utero collection program.

    abstract:BACKGROUND:The greatest limiting factor in the use of umbilical cord blood (UCB) for transplantations is the number of stem cells available in any given collected unit. This study examines maternal, neonatal, and obstetric factors that influence the suitability for banking and transplantation of UCB units collected in ...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.12340

    authors: Keersmaekers CL,Mason BA,Keersmaekers J,Ponzini M,Mlynarek RA

    更新日期:2014-03-01 00:00:00

  • Impact of donor ABH-secretor status in ABO-mismatched living donor kidney transplantation.

    abstract:BACKGROUND:The ABO blood group is a major determinant in living donor kidney transplantation since AB antigens are expressed on renal tissue. Little attention has been directed to the ABH-secretor status of the donor kidney. As renal tissue is capable of secreting soluble ABH antigens in secretors, we examined the infl...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.13711

    authors: Drexler B,Holbro A,Sigle J,Gassner C,Frey BM,Schaub S,Amico P,Plattner A,Infanti L,Menter T,Mihatsch MJ,Stern M,Buser A,Dickenmann M

    更新日期:2016-09-01 00:00:00

  • Iron supplementation by blood donors: demographics, patterns of use, and motivation.

    abstract:BACKGROUND:Iron supplements reduce the risk of iron depletion in blood donors. Recent initiatives have sought to increase use of donor iron supplementation (IS), but a baseline description of blood donor supplement practices is needed. STUDY DESIGN AND METHODS:Presenting blood donors received a questionnaire inquiring...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.15407

    authors: Cable RG,Spencer BR

    更新日期:2019-09-01 00:00:00

  • Unmanipulated HLA-mismatched/haploidentical peripheral blood stem cell transplantation for high-risk hematologic malignancies.

    abstract:BACKGROUND:Haploidentical hematopoietic stem cell transplantation (HSCT) has been increasingly applied in high-risk hematologic patients due to the absence of HLA-matched donors. The aim of this study was to investigate the efficacy and safety of unmanipulated haploidentical allogeneic peripheral blood stem cells trans...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2011.03478.x

    authors: Huang W,Li H,Gao C,Bo J,Wang Q,Zhao Y,Jing Y,Wang S,Zhu H,Dou L,Wang L,Yu L

    更新日期:2012-06-01 00:00:00

  • Red blood cell alloimmunization is associated with lower expression of FcγR1 on monocyte subsets in patients with sickle cell disease.

    abstract:BACKGROUND:Despite the clinical significance of red blood cell (RBC) alloantibodies, there are currently no laboratory tests available to predict which patients may be at risk of antibody formation after transfusion exposure. Given their phagocytic and inflammatory functions, we hypothesized that differences in circula...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.15463

    authors: Balbuena-Merle R,Curtis SA,Devine L,Gibb DR,Karafin MS,Luckey CJ,Tormey CA,Siddon AJ,Roberts JD,Hendrickson JE

    更新日期:2019-10-01 00:00:00

  • Pediatric transfusion medicine: development of a critical mass.

    abstract::Many significant events have occurred in the recent past that beg a broad audience to address the question "What is pediatric transfusion medicine?" Herein, we list some of these events and their relevance below and attempt to provide an answer for this question. Indeed, several issues regarding the subspecialty of pe...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/j.1537-2995.2008.02015.x

    authors: Hillyer CD,Mondoro TH,Josephson CD,Sanchez R,Sloan SR,Ambruso DR

    更新日期:2009-03-01 00:00:00

  • Pathogen safety of a pasteurized four-factor human prothrombin complex concentrate preparation using serial 20N virus filtration.

    abstract:BACKGROUND:Beriplex P/N/Kcentra/Coaplex/Confidex is a four-factor human prothrombin complex concentrate (PCC). Here, we describe the pathogen safety profile and biochemical characteristics of an improved manufacturing process that further enhances the virus safety of Beriplex P/N. STUDY DESIGN AND METHODS:Samples of p...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.14010

    authors: Nowak T,Popp B,Gröner A,Schäfer W,Kalina U,Enssle K,Roth NJ

    更新日期:2017-05-01 00:00:00

  • Transfusion-associated Serratia marcescens infection: studies of the mechanism of action.

    abstract::The growth of two strains of Serratia marcescens in blood components was tested in this study. One of the strains had been implicated in the epidemic of transfusion-associated sepsis experienced in Denmark and Sweden in 1991. In whole blood with a final concentration of 100 colony-forming units per mL of S. marcescens...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1993.331094054615.x

    authors: Gong J,Högman CF,Hambraeus A,Johansson CS,Eriksson L

    更新日期:1993-10-01 00:00:00

  • Absorption of anti-Chido from serum using autologous red blood cells coated with homologous C4.

    abstract::A method is described which absorbs anti-Chido from serum without reducing the strength of other alloantibodies. Autologous red blood cells are coated with homologous C4 by a low-ionic-strength method and then used for the absorption. This is a practical method for removing anti-Chido from serum so that underlying all...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1982.22382224951.x

    authors: Ellisor SS,Shoemaker MM,Reid ME

    更新日期:1982-05-01 00:00:00

  • Hepatitis E virus antibody prevalence, RNA frequency, and genotype among blood donors in Cambodia (Southeast Asia).

    abstract:BACKGROUND:Recent studies conducted in developed countries described hepatitis E virus (HEV) as an emerging infectious threat to blood safety. However, data on HEV among blood donors from southeast Asia are lacking. STUDY DESIGN AND METHODS:Between July and August 2014, we assessed the presence of HEV immunoglobulin (...

    journal_title:Transfusion

    pub_type: 杂志文章

    doi:10.1111/trf.13731

    authors: Nouhin J,Prak S,Madec Y,Barennes H,Weissel R,Hok K,Pavio N,Rouet F

    更新日期:2016-10-01 00:00:00