bluuebunny/crossref_metadata_2025_split huggingface dataset:
Feasibility of blinding in a randomized controlled trial comparing preoperative autologous blood donation and acute normovolemic hemodilution in adult cardiac surgery
Authors: Rubens Fraser D. , Dupuis Jean‐Yves , Robblee James , Rock Gail , Bryson Greg L. , Wells Philip S. 
Published: March 2003

BACKGROUND: Acute normovolemic hemodilution and preoperative autologous donation have been shown to be effective techniques for decreasing the exposure of patients to allogeneic blood during cardiac surgery. They have not, however, been compared to each other, because of perceived difficulties in blinding in such a clinical study. The feasibility of blinding was tested in a pilot trial.STUDY DESIGN AND METHODS: Ten patients were randomly assigned to undergo preoperative autologous blood donation or acute normovolemic hemodilution during cardiac surgery. Patients were blinded during this process by shielding of the arm and by insertion of an intravenous line in each patient. Every attempt was made to blind the clinical staff during and after surgery. The effectiveness of this blinding was determined by using a questionnaire.RESULTS: In the 10 cases, six patients, four surgeons, and one anesthetist answered, “I do not know,” with respect to whether preoperative autologous blood donation had occurred. The remaining people interviewed believed the blinding was unsuccessful. However, correct answers were given by 75 percent of the patients (95% CI, 19‐99%), 83 percent of the surgeons (95% CI, 36‐99.6%), and 66 percent of the anesthetists (95% CI, 29.9‐92.5%). The frequency of correct answers did not differ significantly from the 50 percent expected by chance, but the CIs are wide.CONCLUSIONS: Blinding of patients and all members of the surgical team during both the preoperative donation process and acute normovolemic hemodilution in the operating theater was successful most of the time, as the frequency of correct answers did not differ significantly from the 50 percent expected by chance. However, more accurate estimates of the success of blinding require a study with a larger sample. It is possible that, with a larger series, the physician's ability to determine patient assignment would be significantly better than that by chance alone.
Testing of individual blood donations for HCV RNA reduces the residual risk of transfusion‐transmitted HCV infection
Authors: Legler Tobias J. , Riggert Joachim , Simson Georg , Wolf Cornelia , Humpe Andreas , Munzel Ullrich , Uy Angela , Köhler Michael , Heermann Klaus‐Hinrich 
Published: March 2003

BACKGROUND: To allow cost‐effective RNA testing with NAT techniques, the national authorities of several countries have planned or already introduced tests of mixed specimens, that is, plasma pools.STUDY DESIGN AND METHODS: High‐throughput extraction, amplification, and detection of HCV RNA from individual blood donations were optimized and validated. The feasibility of the method and the frequency of anti‐HCV‐negative, HCV RNA‐positive donations were determined in a prospective study of 27,745 allogeneic and 792 autologous individual donations.RESULTS: The 50‐ and 95‐percent detection limits of the method were determined at 44 IU per mL and 162 IU per mL, respectively (World Health Organization HCV reference material). When 201 HCV RNA‐positive sera were taken as a reference, the sensitivity was 97.5 percent. The assay specificity was determined at 99.77 percent. During a 20‐month period, two seronegative blood donors tested positive in HCV PCR. The viral load of these donations was 6 × 106 and 3 × 107 copies per mL, respectively. Thus, the yield of HCV RNA testing in this study was 7.63 per 100,000 screened donations (95% CI, 1.25‐22.07). In both PCR‐positive donors, seroconversion was found in subsequent blood samples.CONCLUSION: This study compares the feasibility of single‐donation HCV RNA screening, with the detection of a relatively high percentage of window‐phase donations, to data reported from groups using HCV RNA testing of plasma pools. The relative yield of NAT of individual donations versus minipools should be directly investigated in the near future.
Efficacy of HCV core antigen detection during the preseroconversion period
Authors: Couroucé Anne‐Marie , Le Marrec Nadine , Bouchardeau Françoise , Razer Annie , Maniez Michéle , Laperche Syria , Simon Nicole 
Published: March 2003

BACKGROUND: The purpose of this study was to compare the performances of HCV core antigen (HCV Ag) testing with HCV RNA detection during the preseroconversion period.STUDY DESIGN AND METHODS: Six HCV antibody (HCV Ab)‐negative and HCV RNA‐positive blood samples from 6 donors and 135 serial samples from 28 patients who had undergone hemodialysis, collected a mean of 90 days before the detection of HCV Ab, were tested by ELISA for the detection of HCV Ag and by PCR to quantify HCV RNA.RESULTS: Five of the six donors were positive for HCV Ag. The donor with a negative HCV Ag test had the lowest viral load. In the hemodialysis patients, the 43 first specimens of the series were HCV RNA negative. Of the 92 specimens that were HCV RNA positive, 81 (88%) were positive for HCV Ag. Among the 74 samples with more than 105 RNA copies, 71 (96%) were HCV Ag positive. Average time from first viremic bleed to first HCV Ag‐positive bleed was estimated at 2.0 days and that to first HCV Ab‐positive bleed at 50.8 days.CONCLUSION: HCV Ag testing permits the detection of an HCV infection about 1.5 months earlier than the HCV Ab screening tests and an average of only 2 days later than quantitative HCV RNA detection in individual specimens.
The variability of compensatory erythropoiesis in repeated autologous blood donation
Authors: Weisbach Volker , Corbière Carine , Strasser Erwin , Zingsem Jürgen , Zimmermann Robert , Eckstein Reinhold 
Published: March 2003

BACKGROUND: Compensatory RBC production during repeated preoperative autologous blood donation (PABD) shows marked interindividual variability. This study was performed to reveal variables that might be useful to predict the amount of the erythropoietic response to PABD in an individual patient who was not iron deficient.STUDY DESIGN AND METHODS: In a retrospective study, 104 adult patients, 48 women and 56 men (mean age, 59.9 years; range, 18‐82 years) who donated 3 units (450 mL) of autologous blood at weekly intervals for major surgery were investigated. Blood counts, ferritin, and net preoperative RBC production (net RBC production) were determined in all patients, and soluble transferrin receptor and endogenous levels of EPO, SCF, and IL‐1β were measured in 63 patients. Multiple linear regression analysis was used to determine whether the variance of net RBC production was attributable to baseline values of these variables.RESULTS: Net RBC production was not different in patients who received oral iron and patients who did not (384 ± 222 mL vs. 356 ± 158 mL). In both groups, the same two variables consistently showed a significant relationship to net RBC production: the length of the period between the third donation and the last visit was positively related (p = 0.00001 vs. p = 0.0002) and the Hct at baseline was negatively related (p = 0.0002 vs. p = 0.02) with net RBC production. The proportion of variance in net RBC production that was attributable to these two variables was 48.1 percent (r2 = 0.481) and 34.9 percent (r2 = 0.349), respectively.CONCLUSION: RBC production after PABD increases with increasing interval from last donation to surgery. This suggests that the interval from last donation to surgery should be maximized. This can be achieved by organizational measures in combination with the preparation of RBC concentrates in additive solution with a maximum shelf life.
Value of anti‐HBc screening of blood donorsfor prevention of HBV infection: results of a 3‐year prospective study in Northwestern Greece
Authors: Zervou Eleptheria K. , Dalekos Georgios N. , Boumba Demetra S. , Tsianos Epameinondas V. 
Published: March 2003

BACKGROUND: The risk of infection with transfusion‐transmitted viruses has been reduced remarkably. However, a zero‐risk blood supply remains a popular goal. Some authorities have introduced the screening for antibody to HBc (anti‐HBc) as a surrogate test for the presence of several infectious agents. A 3‐year prospective study was conducted in the Epirus region of Greece to determine the prevalence of several blood‐borne viruses. One component of the study was the prevalence of HBV infection markers and the potential value of anti‐HBc testing of donors in this area.STUDY DESIGN AND METHODS: Between January 1, 1995, and December 31, 1997, some 6696 donors were investigated for the presence of HBV infection markers by standard EIAs. Every sample that tested HBsAg‐negative but anti‐HBc‐reactive alone or in combination with either or both antibodies to HBV e antigen (anti‐HBe) and low‐titered antibodies to HBsAg (anti‐HBs <20 mIU/mL) was further investigated for the presence of HBV DNA by a combination of PCR and DNA EIA.RESULTS: Of these 6696 donors, 15.8 percent tested positive for at least one serologic marker of HBV infection (HBsAg prevalence, 0.85%). Anti‐HBc reactivity alone or in combination with either or both anti‐HBe and low‐titered anti‐HBs was found in 282 donors (4.2%). None tested HBV‐DNA positive. No transfusion‐associated HBV infections were recorded in the recipients of the above 282 blood units.CONCLUSION: A moderate prevalence of HBV infection markers was found. However, taking into account previous studies from this region, it appears that the HBsAg prevalence has declined. In addition, the present study cannot recommend the introduction of anti‐HBc screening as a surrogate marker of occult HBV infection. The adoption of this exclusion criterion in this region would result in unacceptably high rejection rates among otherwise healthy donors. The absence of any case of transfusion‐associated HBV infection after the transfusion of all HBsAg‐negative, anti‐HBc‐positive units appears to provide further support for the negative HBV DNA results. Before a consideration of screening donors, efforts must be focused on reducing the number of false‐positive anti‐HBc results.
Sustained decreases in platelet count associated with multiple, regular plateletpheresis donations
Authors: Lazarus Ellen F. , Browning Janet , Norman James , Oblitas Jaime , Leitman Susan F. 
Published: March 2003

BACKGROUND: Transient but significant decreases in platelet counts have been documented to occur in donors undergoing single and serial short‐term plateletpheresis collections. The effect of long‐term regular plateletpheresis on donor platelet counts has not been characterized.STUDY DESIGN AND METHODS: A retrospective study was performed to evaluate the effects of long‐term regular plateletpheresis donation on donor platelet counts. A computerized database containing records of 11,464 apheresis collections from 939 donors over a 4‐year period was queried for serial preapheresis platelet counts. Donors were categorized by sex, age, and cumulative number of donations. The average difference in platelet counts (mΔPC) between each donor's first and last platelet count during this period was calculated for each category. A subgroup of frequent donors was selected for analysis of mΔPC, using the baseline platelet count obtained before the first plateletpheresis procedure.RESULTS: A significant and sustained decrease in platelet count was identified for all donation frequency categories. The frequency of donation correlated directly with decrease in platelet count for all but the highest‐frequency donation group, in which deferrals for low platelet count blunted the extent of the mΔPC. A mean decrease of 40,000 per μL from baseline occurred in the frequent‐donor subgroup. A total of 84 donors (9%) were deferred for low platelet count. The majority returned to donate successfully after temporary deferral.CONCLUSIONS: Regular plateletpheresis donors develop sustained decreases in platelet count. However, clinically significant thrombocytopenia is unusual when rigorous ongoing review and prudent deferral policies are established and followed.
Association of ABO‐mismatched platelet transfusions with morbidity and mortality in cardiac surgery
Authors: Blumberg Neil , Heal Joanna M. , Hicks George L. , Risher William H. 
Published: March 2003

BACKGROUND: The transfusion of ABO‐mismatched platelets has been associated with increased morbidity and mortality during induction therapy for acute leukemia and allogeneic progenitor cell transplantation.STUDY DESIGN AND METHODS: Reported here is a cohort study of 153 patients undergoing primary coronary artery bypass graft or coronary valve replacement surgery by two surgeons in one institution during 1997 and 1998. All statistics employed nonparametric two‐sided tests (Mann‐Whitney; Fisher's exact test).RESULTS: Patients receiving at least one ABO‐mismatched pool of platelets had a significantly longer hospital stay, more days of fever, greater total hospital charges, and more RBC transfusions. Mortality, hours in the intensive care unit, days on antibiotics, and numbers of platelet transfusions were also greater in recipients of ABO‐mismatched platelets, but these differences were of less statistical significance. When the analysis was restricted to the 139 patients who received no more than two pools of platelets, the trends for increased morbidity and mortality (8.6% vs. 1.9%; p = 0.10) in recipients of ABO‐mismatched platelets persisted. The number of RBC transfusions required in this latter cohort was 50 percent greater (mean, 6.1 vs. 9.2; p = 0.02), despite the fact that the number of platelet transfusions given was similar (mean, 1.2 vs. 1.3 pools; p = 0.22).CONCLUSIONS: ABO‐mismatched platelet transfusions are associated with unfavorable outcomes in cardiac surgery, a relationship that remains unexplained. As this association has been found in three cohort studies in various clinical settings, further investigation of this association is warranted.
HFE mutations do not account for transfusional iron overload in patients with acute myeloid leukemia
Authors: Parkkila Seppo , Niemelä Onni , Savolainen Eeva‐Riitta , Koistinen Pirjo 
Published: March 2003

BACKGROUND: Hereditary hemochromatosis (HH) is a HFE gene‐linked disorder affecting 1 of 200 to 400 persons in white populations. It has been proposed that patients with a hematologic malignancy who are receiving frequent RBC transfusions should be screened for HFE mutations. This would identify C282Y homozygotes, who have a high risk of developing severe iron overload.STUDY DESIGN AND METHODS: DNA samples from 128 controls and 23 adult long‐term survivors of acute myeloid leukemia (AML) treated at the Oulu University Hospital (Oulu, Finland) from 1987 to 2000 were examined for the presence of the C282Y and H63D mutations in HFE. All the patients were severely iron‐overloaded, as determined from high serum ferritin values and/or increased storage iron in bone marrow. Phlebotomies were performed in five patients because of the symptoms of iron overload. DNA extracted from the blood was used to amplify HFE gene fragments by the PCR method, after which the amplification products were digested with restriction endonucleases SnaB I and Bcl I, and the restriction fragments were analyzed on agarose gels.RESULTS: No chromosomes with the C282Y mutation were found among the AML patients, and 5 patients (21.7%) were heterozygous for the H63D mutation. In the control group, 13 persons (10.2%) were heterozygous for the C282Y mutation and 26 (20.3%) for the H63D mutation, including 3 C282Y/H63D double heterozygotes.CONCLUSION: HFE mutations do not account for the harmful iron overload that develops in AML patients who receive large quantities of RBC concentrates after intensive chemotherapy.
Administration of G–CSF plus dexamethasone producesgreater granulocyte concentrate yields while causing nomore donor toxicity than G–CSF alone
Authors: Stroncek David F. , Yau Yu Ying , Oblitas Jaime , Leitman Susan F. 
Published: March 2003

BACKGROUND: G–CSF with or without dexamethasone is becoming the standard agent for mobilizing granulocytes for transfusion. The purpose of this study was to determine if the toxicities of G–CSF with or without dexamethasone are offset by greater collection yields and to define the minimum interval that should separate sequential collections.STUDY DESIGN AND METHODS: Twenty donors were studied on three occasions. They were given either dexamethasone (8 mg, by mouth) plus a placebo injection, G–CSF (5 μg/kg, given subcutaneously) plus placebo capsules, or G–CSF plus dexamethasone. Granulocytes were collected by apheresis. A donor symptom survey was administered, and cell counts and blood chemistries were assessed before collection and 1, 2, 7, 14, 21, 28, and 35 days after collection.RESULTS: More granulocytes were collected when G–CSF was given than when dexamethasone was given (41.1 ± 20.4 × 109 vs. 21.0 ± 10.0 × 109; p<0.001), but the use of G–CSF plus dexamethasone produced the greatest yields (67.1 ± 22.0 × 109; p<0.002). When the donors were given dexamethasone alone, 58 percent experienced at least one symptom, compared to 85 percent of those given G–CSF and 75 percent of those given G–CSF plus dexamethasone. In all three regimens, platelet counts fell 19 percent to 24 percent after collection and remained below baseline for 7 to 14 days. Granulocyte counts returned to baseline within 3 to 7 days, but, in all three regimens, a mild granulocytopenia occurred 21 days after collection. With each of the regimens, blood chemistries changed, but the changes were mild and most returned to baseline within 7 days; however, changes in albumin, bilirubin, and AST persisted until 28 days after collection.CONCLUSION: These results support the use of G–CSF plus dexamethasone in granulocyte donors. G–CSF plus dexamethasone resulted in greater granulocyte yields than either agent alone and was associated with donor symptoms and changes in blood cell counts and chemistries similar to those seen with G–CSF alone or dexamethasone alone. Granulocytes can be safely collected a second time after a 7‐day interval; however, for regular donors, it may be best to separate collections by 4 weeks.
Reporting of near‐miss events for transfusion medicine: improving transfusion safety
Authors: Callum Jeannie L. , Kaplan Harold S. , Merkley Lisa L. , Pinkerton Peter H. , Rabin Fastman Barbara , Romans Robert A. , Coovadia Ahmed S. , Reis Marciano D. 
Published: March 2003

BACKGROUND: Half of the reported serious adverse events from transfusion are a consequence of medical error. A no‐fault medical‐event reporting system for transfusion medicine (MERS‐TM) was developed to capture and analyze both near‐miss and actual transfusion‐related errors.STUDY DESIGN AND METHODS: A prospective audit of transfusion‐related errors was performed to determine the ability of MERS‐TM to identify the frequency and patterns of errors.RESULTS: Events and near‐miss events (total, 819) were recorded for a period of 19 months (median, 51/month). No serious adverse patient outcome occurred, despite these events, with the transfusion of 17,465 units of RBCs. Sixty‐one events (7.4%) were potentially life‐threatening or could have led to permanent injury (severity Level 1). Of most concern were 3 samples collected from the wrong patient, 13 mislabeled samples, and 22 requests for blood for the wrong patient. Near‐miss events were five times more frequent than actual transfusion errors, and 68 percent of errors were detected before blood was issued. Sixty‐one percent of events originated from patient areas, 35 percent from the blood bank, and 4 percent from the blood supplier or other hospitals. Repeat collection was required for 1 of every 94 samples, and 1 in 346 requests for blood components was incorrect. Education of nurses and alterations to blood bank forms were not by themselves effective in reducing severe errors. An artifactual 50‐percent reduction in the number of errors reported was noted during a 6‐month period when two chief members of the event‐reporting team were on temporary leave.CONCLUSION: The MERS‐TM allowed the recognition and analysis of errors, determination of patterns of errors, and monitoring for changes in frequency after corrective action was implemented. Although no permanent injury resulted from the 819 events, innovative mechanisms must be designed to prevent these errors, instead of relying on faulty informal checks to capture errors after they occur.
Computer‐assisted audiovisual health history self‐interviewing Results of the pilot study of the Hoxworth Quality Donor System
Authors: Zuck Thomas F. , Cumming Paul D. , Wallace Edward L. 
Published: March 2003

BACKGROUND: The safety of blood for transfusion depends, in part, on the reliability of the health history given by volunteer blood donors. To improve reliability, a pilot study evaluated the use of an interactive computer‐based audiovisual donor interviewing system at a typical midwestern blood center in the United States.STUDY DESIGN AND METHODS: An interactive video screening system was tested in a community donor center environment on 395 volunteer blood donors. Of the donors using the system, 277 completed surveys regarding their acceptance of and opinions about the system.RESULTS: The study showed that an interactive computer‐based audiovisual donor screening system was an effective means of conducting the donor health history. The majority of donors found the system understandable and favored the system over a face‐to‐face interview. Further, most donors indicated that they would be more likely to return if they were to be screened by such a system.CONCLUSION: Interactive computer‐based audiovisual blood donor screening is useful and well accepted by donors; it may prevent a majority of errors and accidents that are reportable to the FDA; and it may contribute to increased safety and availability of the blood supply.
A randomized, blinded trial comparing the hemostatic effects of pentastarch versus hetastarch
Authors: Strauss Ronald G. , Pennell Beverly J. , Stump David C. 
Published: March 2003

BACKGROUND: HES solutions provide a sterile, alternative colloidal fluid to albumin solutions and/or plasma in the management of patients who need plasma volume expansion. Solutions of HES are widely accepted internationally but are used only modestly in the United States, largely because of concerns over hemostasis. STUDY DESIGN AND METHODS: A randomized, blinded, two‐arm trial comparing the hemostatic effects of pentastarch versus hetastarch when infused in the clinically relevant dose of 90 g of HES dissolved in 1.5 L of saline was conducted. Multiple studies of fibrin clot formation, fibrinogen/fibrinolysis, and platelet (PLT) functions were performed before and on multiple occasions for 70 days following HES infusion. RESULTS: Several significant abnormalities of hemostasis assay results occurred following HES infusions, with hetastarch causing significantly greater abnormalities than pentastarch. Individual clotting proteins and blood PLTs fell modestly because of plasma volume expansion and hemodilution. A fall in excess of that caused by hemodilution was demonstrated for von Willebrand factor antigen plus its associated FVIII and ristocetin cofactor activities. The partial thromboplastin time was prolonged, whereas the thrombin time was shortened. Plt function abnormalities were seen in most subjects to a modest degree. Studies of fibrinolysis were normal. CONCLUSIONS: Solutions of hetastarch produce significant abnormalities of some hemostasis laboratory results when infused at clinically relevant doses, but it is unlikely that the modest hemostatic abnormalities produced at these doses per se would lead to clinical bleeding. Hetastarch causes greater hemostatic abnormalities than pentastarch, and because both HES solutions have comparable plasma volume‐expanding effects, it is reasonable to prefer pentastarch as a plasma volume expander.