BACKGROUND: Two plateletpheresis cell separator systems were compared in a paired crossover study with respect to the product quality, the number of platelet (PLT) units per donation, and the donor comfort. STUDY DESIGN AND METHODS: Forty-four female and 47 male donors were distributed to three body weight groups. Double PLT units with 6 x 10(11) PLTs were collected from three Fenwal Amicus Crescendo (AC) and three CaridianBCT Trima Accel (TA) machines. Each donor made one donation on each randomly assigned system and answered a questionnaire on the subjective donor comfort. The answers were scored from 5 (best) to 1 (worst). RESULTS: Based on 182 donations, with 91 donations on AC and TA separators each, 179 runs resulted in double PLT units and three (2xAC, 1xTA) in single units. The white blood cell counts were below 1 x 10(6) in all but eight therapeutic units (8xTA; mean, 1.98 x 10(6)). The mean PLT yield (AC 6.00 x 10(11), TA 5.98 x 10(11)), the collection rate, and the PLT extraction coefficient did not significantly differ between the two devices. Differences of the donor comfort over all groups were only observed for the loudness of the instrument (4.63 AC vs. 4.24 TA, p < 0.001) and the subjective impression of the run time (4.24 AC vs. 4.48 TA, p < 0.05). Male donors greater than 88 kg preferred the TA instruments concerning the impact of the needle, run time, overall experience (p < 0.01 each), and willingness to donate on the same instrument again (p < 0.05). CONCLUSIONS: Only minor differences were observed despite the fact that the AC separators are run with two needles and the TA with one needle.
RCT Entities:
BACKGROUND: Two plateletpheresis cell separator systems were compared in a paired crossover study with respect to the product quality, the number of platelet (PLT) units per donation, and the donor comfort. STUDY DESIGN AND METHODS: Forty-four female and 47 male donors were distributed to three body weight groups. Double PLT units with 6 x 10(11) PLTs were collected from three Fenwal Amicus Crescendo (AC) and three CaridianBCT Trima Accel (TA) machines. Each donor made one donation on each randomly assigned system and answered a questionnaire on the subjective donor comfort. The answers were scored from 5 (best) to 1 (worst). RESULTS: Based on 182 donations, with 91 donations on AC and TA separators each, 179 runs resulted in double PLT units and three (2xAC, 1xTA) in single units. The white blood cell counts were below 1 x 10(6) in all but eight therapeutic units (8xTA; mean, 1.98 x 10(6)). The mean PLT yield (AC 6.00 x 10(11), TA 5.98 x 10(11)), the collection rate, and the PLT extraction coefficient did not significantly differ between the two devices. Differences of the donor comfort over all groups were only observed for the loudness of the instrument (4.63 AC vs. 4.24 TA, p < 0.001) and the subjective impression of the run time (4.24 AC vs. 4.48 TA, p < 0.05). Male donors greater than 88 kg preferred the TA instruments concerning the impact of the needle, run time, overall experience (p < 0.01 each), and willingness to donate on the same instrument again (p < 0.05). CONCLUSIONS: Only minor differences were observed despite the fact that the AC separators are run with two needles and the TA with one needle.