A new protocol for improving efficiency of autologous peripheral blood stem cell collection in patients with high white blood cell counts.

BACKGROUND: Collection efficiency (CE) of peripheral blood stem cell (PBSC) collections is negatively affected by increasing white blood cell (WBC) counts of the patient. This study compared a new optimized mononuclear cell (MNC) collection protocol (OPP) to the standard MNC collection protocol recommended by the manufacturer (STP) for PBSC collection in patients with WBC counts >35 000/µL. STUDY DESIGN AND METHODS: Single-center, retrospective, and observational study of 81 autologous PBSC collections on Fenwal Amicus cell separators in 70 adult patients. RESULTS: Median peripheral WBC count (×103 /µL; 44.2 in OPP group vs 46.5 in STP group) and median CD34+ count (105/µL in OPP group vs 40/µL in STP group) at the beginning of PBSC collection did not differ significantly. Median CE2 (45% vs 31%; P < .001) as well as CD34+ yield of the apheresis product both with regards to median absolute CD34+ content (×106 ; 793 vs 188; P = .001) as well as median CD34+ content (×106 )/kg body weight (8.93 vs 2.51; P = .002) were significantly higher for the OPP. Overall, 18/21 (86%) patients with the OPP obtained their target CD34+ amount with a single apheresis session, compared to 25/50 (50%) with the STP (P = .005). PBSC collections using OPP lasted significantly longer (median 377 minutes vs 260 minutes; P < .001) than with the STP. CONCLUSIONS: The OPP significantly improves CE2 for PBSC collections on Fenwal Amicus cell separators in patients with pre-apheresis WBC counts >35 000/µL and significantly reduces the necessity for multiple apheresis sessions. The OPP is therefore suited to reduce both patient burden and cost in autologous PBSC collection.

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

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 influence of the ABH-secretor status of kidney donors on outcome in ABO-mismatched living donor kidney transplantation. STUDY DESIGN AND METHODS: We retrospectively analyzed all patients who underwent ABO-mismatched kidney transplantation at the University Hospital Basel from September 2005 to October 2013. The ABH-secretor status was determined in all donors by molecular genetic analysis. RESULTS: Of all 55 patients who received transplants, we excluded all patients with donor-specific antibodies (n = 4). Forty-one donors were secretors (78%) and 11 were nonsecretors (22%). Recipients of ABH-secretor donor organs showed a significantly higher glomerular filtration rate throughout the first 6 months posttransplant, whereas no significant influence on posttransplant anti-A/B titers was found. Regression analysis revealed a significant impact on humoral rejection, whereas not on vascular or interstitial rejection in protocol kidney biopsies. CONCLUSION: The donor ABH-secretor status may have an influence on early posttransplant renal function in patients undergoing ABO-mismatched living donor kidney transplantation. Further prospective studies with long-term follow-up are needed to elucidate involved pathomechanisms.

Impact of recipient ABH secretor status on outcome in minor ABO-incompatible hematopoietic stem cell transplantation.

BACKGROUND: The impact of ABO incompatibility on hematopoietic stem cell transplantation (HSCT) outcome is controversial. As ABH substances are expressed on tissues and secreted in body fluids, they could drive an immune response in minor ABO-incompatible HSCT. The aim of the study was to investigate the prognostic role of the recipients' ABH secretor status. STUDY DESIGN AND METHODS: Patients who underwent minor ABO-incompatible HSCT were included. Secretor status was determined either serologically or by molecular genetics. RESULTS: Between March 1996 and June 2012, a total of 176 patients received minor ABO-incompatible HSCT and 150 (85%) were secretors. Incidence and severity of acute graft-versus-host disease (GVHD) and chronic GVHD did not differ between secretors and nonsecretors (cumulative incidences ± standard errors: acute GVHD on Day 100, 41 ± 11 and 46 ± 5%, p = 0.59; chronic GVHD at 2 years, 52 ± 13 and 56 ± 5%, p = 0.62, for secretors and nonsecretors, respectively). Additionally, nonrelapse mortality (NRM) and overall survival (OS) were similar in the two groups (2-year NRM, 27 ± 9 and 23 ± 3%, p = 0.45; 4-year OS, 64 ± 10 and 55 ± 4%, p = 0.28, for secretors and nonsecretors, respectively). CONCLUSION: The recipients' ABH secretor status in minor ABO-incompatible HSCT has no prognostic impact on major transplant outcomes.

Comparison of transfusion efficacy of amotosalen-based pathogen-reduced platelet components and gamma-irradiated platelet components.

BACKGROUND: Trials of transfusions of platelets (PLTs) treated with amotosalen-based pathogen reduction (PR) showed lower corrected count increments (CCIs) compared to conventional PLT components (PCs). However, PR-PLTs and conventional PCs often differed in various factors besides PR. We compared transfusion efficacy of single-donor apheresis PCs treated with PR or gamma irradiation. STUDY DESIGN AND METHODS: Hematologic patients were assigned to receive PR-PLTs or gamma-irradiated conventional PCs, both prepared in PLT additive solution (PAS). One-hour CCI (primary endpoint), 24-hour CCI, time to next PLT transfusion, and transfusion requirement of red blood cells and plasma were analyzed. RESULTS: Forty-four patients assigned to PR-PLTs received 220 PR-PLTs and 136 conventional PCs; 72 controls received 517 conventional PCs. No differences between patient groups were observed for mean (±standard deviation [SD]) 1-hour CCI (11.4 [±4.9] for PR-PLT vs. 11.0 [±4.9] for controls), mean (±SD) 24-hour CCI (6.1 [±4.4] for PR-PLTs vs. 6.2 [±4.8] for controls), and for the other evaluated outcomes. No differences between PC types were observed for mean (±SD) 1-hour CCI (10.6 [±6.7] for PR-PLTs vs. 9.9 [±6.2] for conventional PCs) and mean 24 hour-CCI (3.3 [±3.9] for PR-PLTs vs. 4.2 [±5] for conventional PCs). Thirty-five percent of PR-PLTs and 38% of conventional PCs (p = 0.63) were associated with 1-hour CCIs of less than 7.5. Inadequate 24-hour CCIs were observed for 72% of PR-PLTs and 64% of conventional PCs (p = 0.002). CONCLUSIONS: Transfusion efficacy of single-donor apheresis PCs in PAS treated with amotosalen PR versus gamma irradiation is comparable.

Prognostic value of red blood cell parameters and ferritin in predicting deferral due to low hemoglobin in whole blood donors.

Risk factors for deferral from red blood cell (RBC) donation due to low hemoglobin are not well defined. We analyzed in a large cohort of returning donors the prognostic value of RBC parameters and serum ferritin regarding low hemoglobin levels at the subsequent visit. Between 2004 and 2009, RBC indices and serum ferritin were recorded in 45,533 visits by 7,994 donors. In 689 instances, donation was deferred at the subsequent visit due to low hemoglobin levels (<123 g/l for female donors, <133 g/l for male donors). Pre-donation hemoglobin at the current visit correlated best with hemoglobin at the subsequent visit (R (2) = 0.63), whereas other RBC indices and serum ferritin correlated only poorly (R (2) ≤ 0.15). Similar results were obtained in ROC curve analysis and in multivariable binary logistic regression. A pre-donation hemoglobin within 5 g/l from the deferral threshold (<128 g/l for female, <138 g/l for male donors) predicted below-threshold hemoglobin levels at the subsequent visit with a sensitivity of 52% and a specificity of 94%. In conclusion, pre-donation hemoglobin is a useful marker identifying donors at risk of developing low hemoglobin levels. Diagnostic and therapeutic interventions should be aimed at donors presenting with hemoglobin levels near the threshold of donor deferral.

Prospective change control analysis of transfer of platelet concentrate production from a specialized stem cell transplantation unit to a blood transfusion center.

BACKGROUND AND OBJECTIVES: Specialized centers claim a need for blood component production independent from the general blood transfusion services. We performed a prospective change control analysis of the transfer of platelet (PLT) production for hematological patients at the University Hospital Basel from the Department of Hematology to the Blood Transfusion Centre, Swiss Red Cross, Basel in February 2006. We wanted to demonstrate that neither quality nor transfusion outcome was affected. MATERIAL AND METHODS: Production quantity and efficiency, product quality and transfusion outcome were systematically recorded. A 2-year pretransfer period was compared to a 2 year post-transfer period. RESULTS: After transfer production quantity at the Blood Transfusion Centre increased from 4,483 to 6,190 PLT concentrates. Production efficiency increased with a significant decrease in the rate of expired products (18% vs. 8%; P < 0.001). Product quality showed a slight decrease in median PLT count per unit (2.84 vs. 2.75 × 10(11); P < 0.001) and a slight increase in mean storage time prior to transfusion (3.18 vs. 3.30 days; P < 0.001). Transfusion outcome measured as median corrected count increment one hour post-transfusion (10.5 vs. 10.7; P = 0.3) and the rate of patients with inadequate post-transfusion increment (31.5% vs. 32.1%; P = 0.6) did not differ. CONCLUSION: Supply and quality of PLT products was maintained after the transfer of PLT production to the Blood Transfusion Centre. An optimization of the supply chain process with markedly decreased expiration rates was achieved. These results argue against the need of specialized PLT production sites for selected patient groups.

The value of routine ferritin measurement in blood donors.

BACKGROUND: Iron store deficiency is a common side effect of whole blood donation. Early recognition and reversal of excessive iron loss may avoid symptomatic iron store depletion in blood donors and reduce volunteer loss due to iron deficiency (ID) anemia. STUDY DESIGN AND METHODS: Between 1996 and 2009, a total of 160,612 visits with the intention to donate blood by 23,557 healthy volunteers were recorded at our center. As of 2004, routine serum ferritin testing and additional counseling of donors at risk for donation-induced anemia were implemented. We analyzed the impact of this measure on the hemoglobin (Hb) levels and anemia occurrence in our donor population and in particular in women of childbearing age. Donation rejections due to low Hb counts, the intervals to next donation, and return rates thereafter were also assessed. RESULTS: The introduction of routine serum ferritin analysis resulted in an increase of mean Hb levels in blood donors particularly in women of childbearing age. The incidence of predonation anemia and donation ineligibility due to a low Hb concentration decreased significantly. The return intervals of donors rejected on account of low Hb levels were shortened; however, the return rates thereafter were also curtailed. CONCLUSIONS: Systematic serum ferritin measurements allowed an optimized management of ID in our donors and efficacious prevention of ID anemia.

Crossover randomized controlled trial of the electronic version of the Chinese SF-36.

OBJECTIVES: to verify the feasibility and reliability of the electronic version of Chinese SF-36 based on the Quality-of-Life-Recorder. DESIGN: A crossover randomized controlled trial, comparing a paper-based and an electronic version of the Chinese SF-36, was conducted. According to generated random numbers, interviewees were asked to fill out either the electronic version or the paper version first. The second version was filled in after a pause of at least 10 min. SETTINGS AND PARTICIPANTS: One group of 100 medical students at the School of Medicine of Zhejiang University and the other group of 50 outpatients at a clinic for general practice in Hangzhou City (China) were eventually recruited in this study. RESULTS: The acceptance of the electronic version was good (60% of medical students and 84% of outpatients preferred the electronic version). At the level of eight-scale scores, the mean-difference for each scale (except for general health) between the two versions was less than 5%. At the level of 36 questions, the percentage of "exact agreement" ranged within 64%-99%; the percentage of "global agreement" ranged within 72%-99%; 77% of the kappa coefficients demonstrated "good/excellent agreement" and 23% of the kappa coefficients demonstrated "medium agreement". CONCLUSION: This study, for the first time, can provide empirical basis for the confirmation of the feasibility and reliability of the electronic version of the Chinese SF-36 and may provide an impulse towards widespread deployment of the Quality-of-Life-Recorder in Chinese populations.

Impact of baseline echocardiography on treatment outcome in primary care patients with newly detected arterial hypertension: a randomized trial.

BACKGROUND: The objective of this study was to test whether baseline echocardiography in newly detected hypertension improves left ventricular mass index and blood pressure control. This is a randomized trial with primary care patients. METHODS: After routine clinical work-up 177 consecutive patients with newly detected hypertension were randomized according to result of their echocardiogram (echo group and control group). Treating physicians were encouraged to prescribe angiotensin II receptor antagonist therapy for patients with evidence of hypertensive target organ damage. Mean blood pressure (BP) and echocardiographic left ventricular mass index were measured at baseline and after 6 months of therapy in both groups. RESULTS: More patients with hypertensive target organ damage were identified in the echo group as compared to the control group (58 of 91 [64%] v 42 of 86 [49%] patients (difference 15%, 95% CI 1%-29%). In the echo group, 41 patients (45%) received angiotensin II receptor antagonist therapy as compared to 27 patients (31%) in the control group (difference 14%, 95% CI 0-28%). After 6 months, there were no differences in mean left ventricular mass index, mean diastolic 24-h ambulatory BP monitoring, or mean systolic and diastolic office BP between the two groups. CONCLUSIONS: In patients with newly detected hypertension, baseline echocardiography detects more patients with hypertensive target organ damage, but does not lead to a reduction in left ventricular mass index or improved BP control after 6 months of therapy.

Temperature-Sensitive Indicators for Monitoring RBC Concentrates Out of Controlled Temperature Storage.

OBJECTIVES: The 30-minute rule for RBC concentrates out of controlled temperature storage does not take into account multiple parameters that influence warming of RBC concentrates. This study evaluated two temperature-sensitive indicators (TIs) for monitoring RBC concentrates during transport. METHODS: TI labels (Check-Spot [Harald H. Temmel KG, Gleisdorf, Austria] and Thermoindikator V4 [BASF, Basel, Switzerland]) were attached to RBC concentrates prior to delivery. Duration of transport, ambient temperatures, and label results (valid vs expired) were recorded. We evaluated the proportion of labels discrepant to the 30-minute rule overall and among deliveries 30 minutes or less and more than 30 minutes and compared the rates of valid and expired readings between both TIs. RESULTS: In total, 201 RBC concentrate deliveries (86.6%) lasted 30 minutes or less, and 31 (13.4%) were more than 30 minutes. Forty-six (19.8%) Check-Spot and 37 (15.9%) Thermoindikator V4 results were discrepant to the 30-minute rule. Sixteen (51.6%) and 27 (87.1%) RBC concentrate deliveries more than 30 minutes displayed valid label readings with Check-Spot and Thermoindikator V4, respectively. Rates of expired labels among deliveries 30 minutes or less and valid labels among deliveries more than 30 minutes differed significantly between TIs (P < .01). CONCLUSIONS: TIs identified a considerable number of RBC concentrates whose temperatures may not be adequately reflected by the 30-minute rule. Variability of readings between TIs stresses the necessity of validation prior to implementation.

Cardiovascular risk stratification in unselected primary care patients with newly detected arterial hypertension.

Cardiovascular risk (CVR) stratification in patients with arterial hypertension is essential. Few data are available on CVR factors (CVRFs), hypertensive target organ damage (TOD) and overall CVR in medical outpatients with newly detected arterial hypertension. General medical patients entering the Medical Outpatient Department of the University Hospital Basel, Switzerland, were screened for elevated office blood pressure (OBP of >140/90 mm Hg). Patients with newly detected arterial hypertension (elevated OBP at two consultations) underwent a work-up that included fundoscopy, urinalysis, ambulatory blood pressure (ABP) monitoring, ECG and echocardiography. CVR was calculated according to the 1999/2003 World Health Organization/International Society of Hypertension (WHO/ISH) guidelines. A total of 2615 outpatients were screened. Of 580 patients with elevated first OPB, 207 were treated for hypertension, 98 refused to participate, 8 were early dropouts and 36 had a normal second OBP. Data from 212 patients were analyzed (mean age 53+/-14 years). The first and second OBP readings were 162+/-6/100+/-6 and 153+/-14/96+/-9 mm Hg, respectively. Mean ABP was 134+/-12/83+/-9 mm Hg, and sustained hypertension was found in 76.9% of patients. Among patients with hypertension according to OPB monitoring, 61.3% had 1 or 2 CVRFs, and 33.0% had >or=3 CVRFs. Evidence of TOD, diabetes or associated clinical conditions (ACCs), such as renal or cardiovascular disease, was found in 26.4, 5.6 and 7.1% of patients, respectively. In terms of CVR, 2.4% of patients were at low risk, 25.9% at medium risk and 71.7% at high risk. No differences existed between white coat and sustained hypertensives regarding CVRFs, TOD or ACCs. Comprehensive analysis in patients with newly detected arterial hypertension revealed a surprisingly high prevalence of CVRFs, TOD and ACCs, indicating high CVR in the majority of these patients.

Participation in a quality of care study and consequences for generalizability of general practice research.

BACKGROUND: Non-participation of General Practitioners (GPs) hampers primary care research. Using existing network structures can improve participation, but may introduce sampling effects. OBJECTIVES: To examine the role of network-based recruitment and other determinants of participation, and to estimate effects of sampling and non-participation on generalizability. METHODS: For a study of quality of care assessment, we recruited GPs from a regionally defined population and a GP network. Effects of sampling and non-participation were analysed by comparing characteristics between participants, target samples, and reference data for all German GPs. Factors influencing study participation were assessed in multiple logistic regression. RESULTS: Compared to the regional sample, network GPs were more likely to complete survey questionnaires (92% versus 69%) and to participate in the study (66% versus 23%). Compared to national reference data, study participants from both populations were younger, had a higher level of professional training, and included more men. These differences were already present in the network target sample, but were largely attributable to selective participation in the regional sample. Network membership remained the strongest determinant of participation in multiple logistic regression (odds ratio 5.01; 95% confidence interval 2.53-9.91). A younger age, higher professional training, and membership in the German Society of General Practice were also predictive of participation. CONCLUSIONS: Although network-based recruitment of GPs increases participation rates, sample effects are similar in size and direction as effects of non-participation in the regionally defined population. Careful analysis of participants based on publicly available data is therefore crucial for the assessment of generalizability.