Donor safety in triple plateletpheresis: results from the German and Austrian Plateletpheresis Study Group multicenter trial.

BACKGROUND: The objective was to investigate potential risks for apheresis donors associated with a triple-plateletpheresis (TP) program. STUDY DESIGN AND METHODS: Eleven hemapheresis centers randomly assigned 411 repeat donors (ratio, 1:1.2) to either double plateletpheresis (DP; 185 donors) or TP (226 donors) with a platelet (PLT) target content of at least 5.0×10(11) PLTs/DP and at least 7.5×10(11) PLTs/TP. The primary endpoint was procedure-related postapheresis PLT count of at least 150×10(9) /L (probability, ≥98%). Secondary endpoints were apheresis characteristics and donor adverse reactions. RESULTS: In 6 of 1133 DPs (0.5%) in 4 of 185 donors (2.2%) and in 20 of 1020 TPs (2.0%) in 14 of 226 donors (6.2%), postapheresis PLT counts were below 150×10(9) /L. There were marginal but significant differences in collection efficiency (DP, 69.2±9.1%; TP, 70.9±9.0%; p≤0.0001) and collection rate (DP, 10.4×10(9) ±2.3×10(9) PLTs/min; TP, 10.8×10(9) ±2.3×10(9) PLTs/min; p≤0.005). The PLT yields were 5.9×10(11) ±0.8×10(11) PLTs for DP and 8.3×10(11) ±0.9×10(11) PLT for TP (p≤0.0001) at processing times of 59±13 minutes (DP) versus 80±16 minutes (TP; p≤0.0001). Significant PLT recruitment (1.10±0.14 vs. 1.20±0.23; p<0.0001) was seen for both DP and TP. DP and TP did not differ with regard to venous access problems (VAPs) without discontinuation (3.8% for both), but DP induced fewer VAPs with discontinuation (1.1% vs. 3.0%; p<0.01). Mild citrate toxicity (1.7% vs. 3.9%; p<0.01) and circulatory reactions (0.4% vs. 2.2%; p<0.01) were more often noticed in TP, but caused no increase in discontinuations. CONCLUSIONS: TP results in an increase in mild donor reactions but does not significantly impair donor safety or product quality.

EIT monitors valid and robust regional ventilation distribution in pathologic ventilation states in porcine study using differential DualEnergy-CT (ΔDECT).

It is crucial to precisely monitor ventilation and correctly diagnose ventilation-related pathological states for averting lung collapse and lung failure in Intensive Care Unit (ICU) patients. Although Electrical Impedance Tomography (EIT) may deliver this information continuously and non-invasively at bedside, to date there are no studies that systematically compare EIT and Dual Energy CT (DECT) during inspiration and expiration (ΔDECT) regarding varying physiological and ICU-typical pathological conditions such as atelectasis. This study aims to prove the accuracy of EIT through quantitative identification and monitoring of pathological ventilation conditions on a four-quadrant basis using ΔDECT. In a cohort of 13 pigs, this study investigated systematic changes in tidal volume (TV) and positive end-expiratory pressure (PEEP) under physiological ventilation conditions. Pathological ventilation conditions were established experimentally by single-lung ventilation and pulmonary saline lavage. Spirometric data were compared to voxel-based entire lung ΔDECT, and EIT intensities were compared to ΔDECT of a 12-cm slab of the lung around the EIT belt, the so called ΔDECTBelt. To validate ΔDECT data with spirometry, a Pearson's correlation coefficient of 0.92 was found for 234 ventilation conditions. Comparing EIT intensity with ΔDECT(Belt), the correlation r = 0.84 was found. Normalized cross-correlation function (NCCF) between scaled global impedance (EIT) waveforms and global volume ventilator curves was r = 0.99 ± 0.003. The EIT technique correctly identified the ventilated lung in all cases of single-lung ventilation. In the four-quadrant based evaluation, which assesses the difference between end-expiratory lung volume (ΔEELV) and the corresponding parameter in EIT, i.e. the end-expiratory lung impedance (ΔEELI), the Pearson's correlation coefficient of 0.94 was found. The respective Pearson's correlation coefficients implies good to excellent concurrence between global and regional EIT ventilation data validated by ventilator spirometry and DECT imaging. By providing real-time images of the lung, EIT is a promising, EIT is a promising, clinically robust tool for bedside assessment of regional ventilation distribution and changes of end-expiratory lung volume.

Evaluation of the COM.TEC cell separator in predicting the yield of harvested CD34+ cells.

BACKGROUND: This multicenter study was performed with the intention to evaluate the exactness of the predicted CD34+ cell yield calculated by two leukapheresis programs of the cell separator COM.TEC upon the number of donor's circulating CD34+ cells and the blood volume processed. STUDY DESIGN AND METHODS: Patients and healthy donors (n = 166) received mobilization by chemotherapy and/or granulocyte colony-stimulating factor and underwent CD34+ cell harvest by the leukapheresis programs MNC or RV-PBSC (n = 203). RESULTS: CD34+ cells were collected by 112 harvests on MNC and by 91 collections on RV-PBSC. The median collection efficiency of CD34+ cells was significantly better for the program MNC than for RV-PBSC (p < 0.001): 67% (31-109) vs. 42% (19-100). The collected CD34+ cell yield was in median more exactly by MNC than by RV-PBSC (p < 0.001): 85% (31-176) vs. 59% (22-110) of the predicted value. Concentrates obtained by RV-PBSC showed in median significantly higher percentages of mononuclear cells (p < 0.001) and CD34+ cells (p < 0.001), 86% (43-99) vs. 56% (25-95) and 1.2% (0.2-14.3) vs. 0.4% (0.1-6.0), and had lower contaminations by erythrocytes (p < 0.001) and platelets (p < 0.001), 13 mL (4-48) vs. 25 mL (5-60) and 1.9 x 1011 vs. 3.1 x 1011, than those harvested by MNC. CONCLUSION: The significantly better collection efficiency of CD34+ cells and the more exact prediction of the harvested CD34+ cell yield make the leukapheresis program MNC a safe and efficient procedure. However, concentrates collected by RV-PBSC are of a better cellular quality with a significantly higher percentage of mononuclear and CD34+ cells and a lower contamination by erythrocytes and platelets.

Collection of WBC-reduced single-donor PLT concentrates with a new blood cell separator: results of a multicenter study.

BACKGROUND: A new cell separator (COM.TEC, Fresenius) was recently developed aimed at efficient collection of WBC-reduced single-donor PLT concentrates (SDPs). STUDY DESIGN AND METHODS: Five German centers collected 554 WBC-reduced SDPs with help of the COM.TEC cell separator. Two multicenter cell counting studies were performed at the beginning and at the end of the study to document uniform counting results among the participating centers. RESULTS: A total of 441 (79.6%) PLT collections were included in the study according to the protocol. A total of 342 single-dose and 99 double-dose SDPs were collected. For single-dose SDPs, an average blood volume of 2826 +/- 409 mL was processed in a donation time of 55 +/- 11 minutes. Mean PLT yield of these products was 3.11 x 1011+/- 0.40 x 1011 and the WBC contamination was 0.11 x 106+/- 0.20 x 106. For double-dose SDPs (PLT count, 5.29 +/- 0.93 x 1011), 3943 +/- 639 mL was processed. The average difference between the target and the collected PLT concentration was -2.8 +/- 12.0 percent for single-dose SDPs and -1.8 +/- 9.5 for double-dose SDPs, respectively. The collection efficiency was 53.7 +/- 5.8 percent for single-dose SDPs and 58.2 +/- 6.2 percent for double-dose SDPs. If all results of each sample from the counting study were set to unity (to the mean over all centers), most PLT determinations were very similar to the mean, for example, near or 1 if set to unity. CONCLUSION: The COM.TEC machine makes it possible to obtain WBC-reduced SDPs that comply with current standards.