COLLECTION OF SINGLE DONOR PLATELET CONCENTRATES BY TRIMA ACCEL, COBE/SPECTRA AND AMICUS CRESCENDO DEVICES: A LARGE, PROSPECTIVE-RANDOMIZED, COMPARATIVE-CROSSOVER STUDY


Dagmar Matz, Fränzi Wägli, Ulrike Murer, Monika Furrer and Beat M. Frey Stiftung Zürcher Blutspendedienst SRK, CH-8001 Zürich (www.zhbsd.ch)

BACKGROUND:
Increasing needs of Single Donor Platelet Concentrates (SDPC) and increasing difficulties to recruit apheresis blood donors (APD) require effective, well tolerated apheresis devices (AD) to meet donor’s and blood center’s expectations.

METHODS:
Performance, productivity and tolerability of Trima Accel (TR), Cobe/Spectra (CO) and Baxter/Amicus (AM) ADs were studied prospectively by performing apheresis procedures in randomized, crossover fashion on all three ADs. Statistically, the study required 40 APDs, giving 40x3=120 apheresis donations to detect 20% difference of target values with power of >80%. The ADs were set to collect 3x1011 PLT/donation, ACD:whole blood ratio was 1:11. APD’s blood examinations and determinations of platelet (PLT) content of SDPCs were performed by hemocytometer. Residual leucocytes and red blood cells of SDPCs by flowcytometry. By questionnaire, side effects and individual preferences concerning ADs were evaluated immediately after donation. Informed consent was signed by all donors before study entry. Results are given by mean ± standard deviation, statistical comparisons by student’s t-test and chi-square-test.

RESULTS:
55 (37 m, 18 f) APDs were recruited. On study, there were 6 drop-outs (3 m, 3 f) due to technical (3), product quality (2) and clerical (1) reasons. By study closure, 49 APDs had collected complete data sets (147 apheresis donations) which were eligible for analysis. TR, CO and AM were equivalent in PLT yield (3.2±0.3x1011/U, 3.2?±0.3x1011/U and 3.0±0.5x1011/U. However, the failing rate to meet product specification of >2,7x1011PLT/U were 4% (TR), 6% (CO) and 24% (AM) (p<0.01,<0.025) resp. Major differences between ADs were seen in collection time (CT,min) TR:41±7, CO:62±10, AM:47±7 (p<0.05 all comb.), processed blood volume, infused amount of ACD, degree of leucodepletion and other parameters. We recognized variable suitability of ADs depending on APD’s sex, and other individual factors.

CONCLUSIONS:

  • Modern apheresis devices allow to reliably collect SDPCs of acceptable PLT content and product quality.
  • As CT is of increasing importance for the donor, TRIMA and AMICUS devices are advantageous.
  • Despite availability of sophisticated equipment, specific properties of APD and AD are important, when chosing an AD for donation. Therefore, collection sites should run various AD types to comply with specific APD’s needs.
  • Decreasing donor availablity will render indispensable most efficient ADs as they might allow to collect more double donations within acceptable time and offer better comfort to the donor.