Process Improvement by Eliminating Mixing of Whole Blood Units after an Overnight Hold Prior to Component Production Using the Buffy Coat Method

Table 3

Quality of red cell concentrates produced with and without mixing. Sample size was 20 pairs (mixed/not mixed) for all parameters. All QC criteria (parameters in bold) were met and noninferiority of RBCs produced without mixing was confirmed for all parameters.

Testing time	Parameter	Study arm	Mean ± SD	Passed QC?; (pass rate)	Difference; (95% CI)
Day 3	rWBC/unit	NM	1.18×10^5±7.11×10^4	Yes (100%)	0.89; (−3.62, 5.41) × 10^4
		M	1.27×10^5±9.96×10^4	Yes (100%)
	Hemoglobin (g/unit)	NM	52.5 ± 1.53	Yes (100%)	−0.061; (−0.499, 0.376)
		M	52.4 ± 1.40	Yes (100%)
	Hematocrit (L/L)	NM	0.626 ± 0.009	Yes (100%)	−0.002; (−0.006, 0.002)
		M	0.624 ± 0.008	Yes (100%)
	Hemolysis (%): hemoCue/ADVIA	NM	0.045 ± 0.042	N/A	−0.011; (−0.029, 0.006)
		M	0.033 ± 0.023	N/A
	Hemolysis (%): Drabkin’s	NM	0.084 ± 0.019	N/A	0.001; (−0.007, 0.008)
		M	0.084 ± 0.021	N/A
	Supernatant potassium (mM)	NM	5.830 ± 0.207	N/A	−0.095; (−0.175, −0.015)
		M	5.735 ± 0.220	N/A
Day 43	Hemoglobin (g/unit)	NM	52.3 ± 1.47	Yes (100%)	−0.128; (−0.575, 0.318)
		M	52.2 ± 1.64	Yes (100%)
	Hematocrit (L/L)	NM	0.649 ± 0.011	Yes (100%)	−0.004; (−0.006, 0.002)
		M	0.646 ± 0.009	Yes (100%)
	Hemolysis (%): hemoCue/ADVIA	NM	0.162 ± 0.044	Yes (100%)	0.016; (0.002, 0.029)
		M	0.178 ± 0.039	Yes (100%)
	Hemolysis (%): Drabkin’s	NM	0.198 ± 0.034	N/A	0.012; (−0.008, 0.032)
		M	0.210 ± 0.036	N/A
	Supernatant potassium (mM)	NM	40.460 ± 1.898	N/A	−0.615; (−1.259, 0.029)
		M	39.845 ± 1.484	N/A

SD: standard deviation, QC: quality control, CI: confidence interval, NI: noninferiority, rWBC: residual white blood cells, M: mixed, NM: not mixed, and N/A: not applicable.