bluuebunny/crossref_metadata_2025_split huggingface dataset:
Statistical process monitoring of WBC‐reduced blood components assessed by two types of software
Authors: Seghatchian Jerard , Krailadsiri Pranee , McCall Michael 
Published: March 2003

BACKGROUND: Statistical process control is required for monitoring of the WBC‐reduction process. This study focused on some factors that may influence the outcomes of statistical process monitoring, such as WBC‐reduction technologies, the anticoagulant used, and WBC‐counting technologies, by using two types of software.STUDY DESIGN AND METHODS: Data were collected from January to September 1999, before the implementation of universal WBC reduction. The effects of three major factors were investigated: methods of preparation, the addition of EDTA to the sample, and the WBC‐counting technologies used (microvolume fluorimetry, flow cytometry, and Nageotte chamber). The WBC‐reduction process capability was assessed by two types of software, EZQC (Gambro BCT) and NWA (Northwest Analytical). In addition, the differences between various sets of results were compared by the t test or ANOVA.RESULTS: There was no statistical difference (at the 0.05 level of significance) in WBC content when the three types of platelets in citrate samples were compared with EDTA samples. In general, the Nageotte chamber appeared to count the lowest, and microvolume fluorimetry appeared to count lower than flow cytometry. There were minor but significant methodologic differences between the software packages. However, these differences had negligible effects on the percentage of conforming components at both <1 × 106 and <5 × 106 WBCs per unit.CONCLUSION: Only the counting technologies were sufficiently different to warrant consideration. This difference may make unacceptable the interchange of results obtained from various counting methods.
Seroprevalence of known and putative hepatitis markers inUnited States blood donors with ALT levels at least 120 IU per L
Authors: Notari Edward P. , Orton Sharyn L. , Cable Ritchard G. , Grindon Alfred J. , Lenes Bruce A. , Williams Alan E. , McMillan Kimberly M. , Trouern‐Trend Jonathan J. , Wolf‐Nugent Jennifer S. , Xu Yi‐Ling , Dodd Roger Y. ,   for the ARCNET Program
Published: March 2003

BACKGROUND: ALT testing of blood donors was initiated as a surrogate marker for non‐A, non‐B hepatitis. Increased sensitivity of subsequent HBV and HCV tests used for standard donor screening make any residual value of ALT testing questionable.STUDY DESIGN AND METHODS: A prospective study was conducted in 166 of 645 eligible blood donors from three American Red Cross regions whose ALT was ≥120 IU per L and whose standard donor screening tests were negative. Of these enrolled donors, 124 (75%) completed follow‐up. Samples obtained from the index donation, at enrollment (1 month), and at follow‐up (6 months) underwent the standard donor screening tests, as well as those for HCV RNA and HGV RNA (RT‐PCR), antibodies to the virus envelope E2 protein of GB virus type C (GBV‐C E2 antibody), and IgM antibody for CMV, parvovirus B19, EBV VCA, and HAV. Participants completed a brief demographic and exposure history questionnaire at follow‐up.RESULTS: All study samples were negative in standard donor‐screening tests. ALT levels were variable at return visits, with 80 to 86 percent <120 IU per L. No participants were positive for HCV RNA; 4 percent were positive for HGV RNA, and 10 percent were positive for GBV‐C E2 antibody. Results of CMV, parvovirus B19, EBV VCA, and HAV testing were similar to published background rates. No demographic or exposure history variables had significant correlation with ALT or other testing results.CONCLUSION: These data suggest that an ALT ≥120 IU per L in blood donors with negative standard screening tests has questionable value as a surrogate marker for seronegative HBV or HCV infection. Continued ALT testing may contribute little, if anything, to the safety of blood components or plasma for further manufacture.
Platelet alloantibodies in transfused patients
Authors: Kiefel Volker , König Claudia , Kroll Hartmut , Santoso Sentot 
Published: March 2003

BACKGROUND: Patients receiving cellular blood components may form HLA antibodies and platelet‐specific alloantibodies.STUDY DESIGN AND METHODS: Serum samples from a cohort of 252 patients with hematologic or oncologic diseases who are receiving cellular blood components were studied for platelet‐reactive antibodies. Specificity of platelet alloantibodies was determined with a panel of typed plateletsRESULTS: Platelet‐reactive antibodies were detected in the sera of 113 patients (44.8% of 252), HLA antibodies in the sera of 108 (42.9%), and platelet‐specific antibodies in the sera of 20 (8%). The following platelet‐specific antibodies were identified: anti‐HPA‐5b (n = 10), anti‐HPA‐1b (n = 4), anti‐HPA‐5a (n = 2), anti‐HPA‐1a (n = 1), anti‐HPA‐2b (n = 1), anti‐HPA‐1b+5b (n = 1), and anti‐HPA‐1b+2b (n = 1). Fifteen sera from the 108 patients with anti‐HLA (13.9%) contained additional platelet‐specific alloantibodies, while in 5 sera, platelet‐specific alloantibodies only were detected: anti‐HPA‐5b (n = 4) and anti‐HPA‐1a (n = 1). Of the 108 sera with HLA antibodies, 29 (26.9%) showed discordant results when studied with the lymphocytotoxicity test and the glycoprotein‐specific immunoassay. Ten sera contained panreactive antibodies against platelet glycoproteins (GP) IIb/IIIa, GPIa/IIa, and/or GPIb/IX. Alloimmunization occurred in 58.3 percent of female patients with previous pregnancies, but in only 23.3 percent of those without previous pregnancies (p = 0.0049).CONCLUSION: Platelet alloantibody specificities in transfused patients (predominantly anti‐HPA‐5b and ‐1b with antigen frequencies <30% among whites) differ significantly from those observed in patients with neonatal alloimmune thrombocytopenia or posttransfusion purpura, in whom anti‐HPA‐1a (antigen frequency >95%) is the most prevalent specificity. HLA antibody detection yields discordant results when the lymphocytotoxicity assay and a glycoprotein‐specific immunoglobulin‐binding assay are used.
MCV as a guide to phlebotomy therapyfor hemochromatosis
Authors: Bolan Charles D. , Conry‐Cantilena Cathy , Mason Glorice , Rouault Tracey A. , Leitman Susan F. 
Published: March 2003

BACKGROUND:A multitude of recommendations exist for laboratory assays to monitor the pace and endpoints of phlebotomy therapy for hemochromatosis. All of these recommendations rely on an assessment of storage iron to guide treatment, and none have been prospectively evaluated.STUDY DESIGN AND METHODS:Nine consecutive patients underwent serial monitoring of Hb, MCV, transferrin saturation, and ferritin during weekly phlebotomy to deplete iron stores (induction therapy) and less frequent sessions to prevent iron reaccumulation (maintenance therapy). Changes in MCV and Hb were used to guide the pace of phlebotomy over a median of 7 years of follow‐up.RESULTS:During induction therapy, the MCV increased transiently because of reticulocytosis and then stabilized for a prolonged period before decreasing more sharply, which reflected iron‐limited erythropoiesis. Iron depletion was achieved after a median of 38 phlebotomies and removal of 9.0 g of iron. Maintenance phlebotomy was targeted to maintain the MCV at 5 to 10 percent below prephlebotomy values and the Hb at >13 g per dL. Transferrin saturation fluctuated considerably during treatment, but remained below 35 percent during MCV‐guided maintenance therapy. Ferritin values were not useful guides to the pace of phlebotomy. The median maintenance therapy phlebotomy interval was 7.5 weeks (range, 6‐16), which corresponded to an average daily iron removal of 35 to 67 μg per kg. Most patients showed evidence of iron reaccumulation at phlebotomy intervals of 8 weeks or more.CONCLUSION:The MCV is an inexpensive, precise, physiologic indicator of erythropoietic iron availability. When used in conjunction with the Hb, it is a clinically useful guide to the pace of phlebotomy therapy for hemochromatosis.
WBC‐reduced platelet concentrates from pooled buffy coats in additive solution: an evaluation of in vitro and in vivo measures
Authors: Van Der Meer Pieter F. , Pietersz Ruby N.I. , Tiekstra Margriet J. , Huijgens Peter C. , Dekker Wil J.A. , Reesink Henk W. 
Published: March 2003

BACKGROUND: The use of a platelet additive solution (PAS‐II, Baxter) may have benefits over plasma for storage of platelets. It was the aim of this study to develop a method to produce WBC‐reduced platelet concentrates (PCs) in PAS‐II with >240 × 109 platelets and <1 × 106 WBCs per unit, which can be stored for 5 days at pH >6.8 and that will give sufficient platelet increments after transfusion: a 1‐hour CCI of >7.5 and a 20‐hour CCI of >2.5.STUDY DESIGN AND METHODS: PCs were made from five pooled buffy coats and 250 g of PAS‐II. After centrifugation the PCs were WBC‐reduced with a filter (Autostop BC, Pall Biomedical) and stored in a 1000‐mL polyolefin container. CCIs were assessed in stable hemato‐oncologic patients after 5‐day old PCs were transfused.RESULTS: Routinely produced PCs contained a median of 310 × 109 platelets (n = 5,363) with 3.5 percent containing <240 × 109 platelets, in a median volume of 320 mL (n = 11,834). The median number of WBCs was <0.03 × 106 (n = 694). The WBC count exceeded 1 × 106 in three PCs, but it was always <5 × 106, giving 99‐percent confidence that more than 99.5 percent of the units will contain <1 × 106 WBCs. The pH remained >6.8 on Day 8, provided the concentration was below 1.1 × 109 platelets per mL (n = 32). After 28 transfusions in 28 patients, the 1‐hour CCI was 12.6 ± 4.3 (mean ± SD, with 2/28 CCIs <7.5) and the 20‐hour CCI was 8.9 ± 5.6 (with 4/28 CCIs <2.5). Limitations of this study include the absence of a control group of patients receiving platelets stored in plasma and of in vivo radiolabeled survival studies, but a comparison of these data with previously published data suggested that the in vivo survival of platelets stored in PAS‐II is less than that of platelets stored in plasma.CONCLUSION: The WBC‐reduced PCs conformed to specifications. These WBC‐reduced PCs could be stored at least 5 days with maintenance of pH, and they gave sufficient increments after transfusion to patients.
A novel RT‐PCR for reliable and rapid HCV RNA screening of blood donations
Authors: Hennig Holger , Luhm Jurgen , Hartwig Dirk , Klüter Harald , Kirchner Holger 
Published: March 2003

BACKGROUND: The objective of this work was to develop a novel and highly sensitive RT‐PCR method that is suitable for HCV RNA screening of blood donations according to the criteria released by the Paul Ehrlich Institute, the federal licensing agency of Germany, for routine HCV NAT.STUDY DESIGN AND METHODS: RNA was prepared from plasma pools of up to 20 single blood donations using an automated nucleic acid isolation system (NucliSens Extractor, Organon Teknika). For reverse transcription, amplification, and simultaneous detection of PCR products, a novel approach based on the TaqMan technology was developed. Glyceraldehyde‐3‐phosphate dehydrogenase messenger RNA, which is detectable in human plasma, was coamplified in each reaction as an internal positive control.RESULTS: The HCV genotypes and subtypes 1a, 1b, 2a, 2b, 2c, 2i, 3a, 4, and 5a were detected in parallel with comparable amplification efficiency. The 95‐percent detection limit related to the WHO HCV RNA standard preparation was calculated to be 389 IU per mL of plasma of the single blood donation. Total CVs (%) were <4. The screening of up to 180 blood donations took 5 hours; as a rule, the blood components could be released on the day of donation.CONCLUSION: The TaqMan HCV RT‐PCR is an almost completely automated, highly sensitive, specific, and rapid method that is reliable for HCV RNA screening of blood donations. It allows a closed‐tube HCV RNA detection without risk of contamination by PCR products.
Identifying allogeneic platelets by resolution of point mutations in mitochondrial DNA using single‐stranded conformational polymorphism PCR
Authors: Garritsen Henk S.P. , Hellenkamp Frank , Hoerning Andre , Mittmann Karin , Sibrowski Walter 
Published: March 2003

BACKGROUND: The purpose of this study was to evaluate single‐stranded conformational polymorphism (SSCP)‐PCR utilizing two different regions of mitochondrial DNA (mtDNA) as a method to discriminate between donor platelets and recipient cells.STUDY DESIGN AND METHODS: Twenty‐eight mixtures of platelets (1:1 ratio) were prepared from eight randomly selected persons to simulate donor–recipient combinations after allogeneic platelet transfusion. The mtDNA was extracted from each donor and each prepared mixture. Four primer pairs were designed to amplify two regions of mtDNA, hypervariable region (HVR) 1 and 2. An SSCP‐PCR method was developed to analyze the four different amplicons. In addition, the amplified DNA samples containing HVR1 and HVR2 mtDNA of the eight persons were sequenced by using dye‐terminator cycle sequencing to determine mtDNA polymorphisms.RESULTS: With four different primer pairs and SSCP‐PCR, it was possible to discriminate between donor and recipient DNA in all 28 combinations. DNA sequencing confirmed that the suspected differences were localized within the amplicons examined by SSCP‐PCR.CONCLUSION: SSCP‐PCR analysis targeting the HVR1 and HVR2 mtDNA is a promising new method to potentially identify donor cells on the basis of mtDNA polymorphisms. The method does not require prior knowledge of sequence differences between donor and recipient and can be optimized to quantify the amount of residual transfused allogeneic platelets.
The impact of the intensity of serial automated plasmapheresis and the speed of deep‐freezing on the quality of plasma
Authors: Hellstern Peter , Bach Jürgen , Haubelt Hannelore , Hitzler Walter E. , Mathis Sabine , Vogt Anette 
Published: March 2003

BACKGROUND: Data are lacking on the impact that the intensity of serial donor plasmapheresis has on the quality of source plasma. A study was conducted to examine the quality of source plasma produced by intensive plasmapheresis and slow deep‐freezing and to compare it to source plasma manufactured by moderate plasmapheresis and rapid freezing.STUDY DESIGN AND METHODS: Seventy‐five plasma samples from intensive plasmapheresis programs (Group 1) and 75 plasma units from moderate plasmapheresis programs (Group 2) were examined. The plasma had been deep‐frozen either slowly at –30°C in walk‐in freezers (Group 1) or rapidly within 1 hour to a core temperature below –30°C (Group 2). Determinations were made of the plasma levels of citrate; total protein; albumin; IgG; fibrinogen; factors II, V, VII, VIII, and IX; vWF; antithrombin; protein C; D‐dimers; and prothrombin fragments 1+ 2.RESULTS: Plasma units of Group 2 contained substantially greater levels of citrate, IgG, FVIII, and FV than samples of Group 1 (p<0.0001). Plasma levels of total protein, albumin, and fibrinogen also were higher in Group 2 (p<0.0001, p = 0.007, and p = 0.006, respectively). Neither plasmapheresis intensity nor freezing procedure had any influence on the levels of factors II, VII, and IX, antithrombin, or protein C. There was no evidence of substantial coagulation activation in the plasma units of either group. However, higher FVIII clotting activity/chromogenic substrate activity ratios in rapidly frozen plasmas and a significant correlation between these ratios and prothrombin fragment 1+ 2 levels suggest that rapid freezing yields both more native FVIII and greater partial activation of FVIII.CONCLUSION: Source plasma collected from donors undergoing intensified plasmapheresis contains markedly lower levels of IgG than plasma units produced by moderate serial plasmapheresis. The combination of intensified plasmapheresis and slower freezing of source plasma results in substantially lower levels of FV and FVIII than does moderate plasmapheresis with rapid freezing. Prospective studies should establish the optimum conditions required for the safe and economic production of source plasma for fractionation.
Pharmacokinetic analysis of plasma‐derived and recombinant F IX concentrates in previously treated patients with moderate or severe hemophilia B
Authors: Ewenstein Bruce M. , Joist J. Heinrich , Shapiro Amy D. , Hofstra Thomas C. , Leissinger Cindy A. , Seremetis Stephanie V. , Broder Martin , Mueller‐Velten Guenther , Schwartz Bruce A. ,   Mononine Comparison Study Group
Published: March 2003

BACKGROUND: Hemophilia B is an X‐linked bleeding disorder that affects approximately 1 in 25,000 males. Therapy for acute bleeding episodes consists of transfusions of plasma‐derived (pd‐F IX) or recombinant (r‐F IX) concentrates. STUDY DESIGN AND METHODS: A double‐blind, two‐period crossover study was initiated to assess the pharmacokinetics of pd‐F IX and r‐F IX and to address patient‐specific variables that might influence in vivo recovery. Study product was administered by a single bolus infusion (50 IU/kg) to 43 previously treated patients in the nonbleeding state, and F IX:C levels were measured over a period of 48 hours after infusion. RESULTS: The mean in vivo recovery in the pd‐F IX group was 1.71 ± 0.73 IU per dL per IU per kg compared with 0.86 ± 0.31 IU per dL per IU per kg with r‐F IX (p ≤ 0.0001). There was a significant positive correlation (Pearsons r = 0.62, p ≤ 0.0001, 95% CI, 0.37–0.78) between the recoveries of the two products and a weak correlation between the recovery of pd‐F IX and baseline F IX:Ag levels. There was no significant difference in the terminal half‐lives of the two products. CONCLUSIONS: The study found wide product‐ and patient‐related variability in recovery. Inherent differences among patients, including baseline F IX, may account for some of the interpatient variability. These differences should be taken into account in optimizing treatment regimens for individual patients with hemophilia B.
Outcome of an optional HCV screening program for blood transfusion recipients in Ireland
Authors: Davoren Anne , Dillon Annette D. , Power Joan P. , Donnellan Joe , Quinn Jacqueline M. , Willis Joe W. , Lawlor Emer M. , O'Riordan Joan M. 
Published: March 2003

BACKGROUND: An optional (general) HCV testing program for blood and blood component recipients before the introduction of routine donor anti‐HCV screening (October 1991) was launched in Ireland in 1995 to complement the targeted lookback program in progress at that time and to identify transfusion‐transmitted hepatitis C. STUDY DESIGN AND METHODS: The public were informed of the opportunity to avail of screening by widespread media coverage. Screening was by an initial ELISA (Abbott 3.0, Abbott Laboratories) at the transfusion center laboratories. Reactive samples were referred to a virus reference laboratory where two additional ELISAs (Ortho 3.0, Ortho Clinical Diagnostics; and Murex 3.0, Murex) were performed. Confirmation of ELISA‐positive samples was by a RIBA (RIBA 3.0, Chiron Corp.). All patients found to be anti‐HCV‐ seropositive were tested for HCV RNA by PCR and were referred to a hepatologist. RESULTS: A total of 14,917 persons have been tested for hepatitis C in this program to date (85% women). Sixty‐one people were confirmed positive for HCV by RIBA 3.0 (0.4%). Excluding persons with other risk factors (n = 15), the HCV positivity rate for blood component transfusion recipients (n = 46) was 0.3 percent. Of the 46 confirmed hepatitis C‐positive blood component transfusion recipients, 32 were women (70%), 24 of whom received transfusion for obstetric or gynecologic indications (75%). Thirty‐eight of 46 (83%) anti‐HCV seropositive transfusion recipients tested had detectable HCV RNA by PCR. CONCLUSION: This program identified 46 transfusion recipients and 10 coagulation factor concentrate recipients, all of whom were previously unaware of their infection. The majority of HCV‐positive transfusion recipients identified were women. This may reflect that women are longer living survivors of transfusion therapy or alternatively, in our experience, that Irish women perceive themselves at greater risk of hepatitis C because of the well‐publicized association of this virus with recipients (women) of Irish RhIG.
Thrombotic microangiopathy in blood and marrow transplant patients receiving tacrolimus or cyclosporine A
Authors: Sarkodee‐Adoo Clarence , Sotirescu Dan , Sensenbrenner Lyle , Rapoport Aaron P. , Cottler‐Fox Michele , Tricot Guido , Ruehle Kathy , Meisenberg Barry 
Published: March 2003

BACKGROUND : Cyclosporine A (CSA) and tacrolimus (FK‐506) are both associated with thrombotic microangiopathy (TMA) in allogeneic BMT recipients, although it is not known which drug is more likely to cause the syndrome. The optimal treatment of BMT‐associated TMA is also not known. STUDY DESIGN AND METHODS : To estimate the risks, predisposing factors, and outcomes of TMA, data were analyzed from two cohorts of BMT patients who had received CSA or FK‐506 in our institution with the same clinical definition for TMA. TMA was diagnosed in 11 of 55 patients (CSA, 3 of 24; FK‐506, 8 of 31). RESULTS : The daily risk of developing TMA was 0.12 percent for patients receiving CSA and 0.26 percent for those receiving FK‐506 (p = 0.16, chi‐square). Among patients receiving FK‐506, sibling donor BMT recipients were as likely to develop TMA as matched unrelated donor recipients. Serum CSA and FK‐506 concentrations were not elevated above the therapeutic range in most patients with TMA. The blood urea nitrogen to serum creatinine ratio was elevated in patients with TMA. Despite daily plasmapheresis, 9 of 11 patients died without resolution of TMA; however, the causes of death were multifactorial, including GVHD. Histologic evidence for TMA was absent in 1 patient who died with persistent clinical signs attributed to microangiopathy. CONCLUSIONS : In this study, a high incidence of TMA was found in patients receiving either CSA or FK‐506 following BMT, with uniform diagnostic criteria and strict monitoring. Neither drug showed elevated levels in most patients with TMA. Plasmapheresis was unsuccessful in reversing most cases of TMA.