Transfusion results of cytapheresis platelet concentrates stored in two different polyolefin containers for five days.

OBJECTIVE: Two different types of polyolefin storage containers were compared in order to estimate their ability to preserve apheresis platelet concentrates for 5 days. MATERIAL AND METHODS: Ten pairs each consisting of one patient with thrombocytopenia following chemotherapy and one healthy platelet apheresis donor were examined. The platelet concentrates stored in the LE-2 bag were collected with a Fresenius AS 104 cell separator and those stored in the PL 732 with a Fenwal CS 3000. RESULTS: The separation efficiency of both cell separators was similar; the mean yields were 3.37 +/- 0.83 x 10(11) platelets in 274 +/- 26 ml for the AS 104 and 3.87 +/- 1.31 x 10(11) platelets in 318 +/- 22 ml for the CS 3000 (mean +/- SD). Storage for 5 days did not influence the platelet count significantly. The platelet loss due to filtration was 16 and 13%, respectively. The mean platelet volume obtained with both systems was reduced from a mean of 8.4 fl immediately after harvesting to 7.6 fl after storage (p < 0.0001) and to 7.3 fl after filtration (p = 0.001). The established corrected count increments (CCI) and the pre- and posttransfusion platelet counts were satisfactory and comparable for the 2 systems tested. The mean CCI of the AS 104-LE-2 system was 14.5 1 h and 7.4 x 10(9) platelets 24 h after transfusion, the mean CCI of the CS 3000-PL 732 system was 12.5 and 5.2 x 10(9) platelets, respectively. CONCLUSIONS: Single-donor apheresis concentrates with a large platelet content may be stored in the new LE-2 polyolefin container for up to 5 days and used in clinical transfusion.

Biocompatibility studies of the single-needle technique in plateletpheresis with the Fresenius AS 104 blood cell separator.

To investigate the biocompatibility of the single-needle technique of the Fresenius AS 104 blood cell separator we analyzed coagulation, complement and hemolysis parameters prior to, during and after five thrombocytaphereses. The data were compared with results of the same parameters from identical donors in the dual-needle procedure. The analysis of bilirubin, lactate dehydrogenase, hydroxybutyrate dehydrogenase and haptoglobin showed no relevant hemolysis. However, changes of the concentrations of coagulation factors XII and XI indicated an activation of coagulation. This was confirmed by an increase of the thrombin-antithrombin III complex during apheresis. No significant change in the complement split product content of the samples obtained during apheresis was found. Complement factors, glucose, lactate, leukocytes, morphology score and thrombocytes were measured in platelet concentrates. The comparison of the platelet products showed no significant differences except for leukocyte contamination. Glucose and lactate concentrations were similar in both procedures. Levels of complement activation markers were not statistically different.

[Second multicenter study of thrombocytapheresis using the Fresenius AS104 blood cell separator and ring study for quality control of cell counts. Members of the Preparative and Therapeutic Hemapheresis Section of DGTI]. / Zweite Multizentrische Studie zur Thrombozytapherese mit dem Blutzellseparator Fresenius AS 104 und Ringstudie zur Qualitätskontrolle der Zellzählung. Mitglieder der Sektion Präparative und Therapeutische Hämapherese der DGTI.

The aim of the 2nd Multicenter study was to evaluate the separation protocol software version V 4.61 of the Fresenius AS 104 cell separator, for separation efficiency, WBC contamination and yield's deviation from prediction. Plateletpheresis data from 12 hemapheresis centers, using identical apheresis protocols and cell counting methods, were registered and statistically analyzed. Additionally, the counting methods of the centers were controlled by a ring study with biweekly cell counts. To get a comparison the apheresis data, which were dependent of the center effects, were corrected by the systematical deviation found in the quality control from the ring study. The results of 935 runs are 47.3 +/- 8.1% for the separation effectivity. 7.2% median deviation from predicted yield, whereby 90% of all runs deviated less than +/- 22% from predicted yields. 50% of products had a WBC contamination below 6 x 10(6), 99% below 5 x 10(7).

[Preliminary results of the 2nd multicenter study. Thrombocytapheresis with the Fresenius AS-104 blood cell separator and ring study of cell counting. Section of Therapeutic and Preparative Hemapheresis of the DGTI]. / Vorläufige Ergebnisse der 2. Multizentrischen Studie. Thrombozytapherese mit dem Blutzellseparator Fresenius AS-104 und der Ringstudie zur Zellzählung. Sektion Therapeutische und Präparative Hämapherese der DGTI.

Only multicenter studies on cell separators give valid data to compare different cell separators. The aim of the 2nd multicenter study was to evaluate the separation protocol, software version V 4.61, of the Fresenius AS-104 cell separator for efficiency and deviation from predicted yields. Plateletpheresis data from twelve hemapheresis centers, using identical apheresis protocols and cell counting methods, were registered and statistically analyzed. Additionally, the counting methods of the centers were controlled by a ring study with biweekly external cell count trials. To get a comparison, the apheresis data, which depend on the center effects, were corrected by the values from the ring study. Preliminary results of 380 runs are 45.2 +/- 8.1% for the separation effectivity, 1.95% deviation from the predicted yield, whereby 90% of all runs deviated less than 20% from the predicted yield. 50% of products had a WBC contamination below 6 x 10(6).