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
Yes
0.89 (−3.62, 5.41) × 104
M
Yes
Hemoglobin (g/unit)
NM
52.5 ± 1.53
Yes
−0.061 (−0.499, 0.376)
M
52.4 ± 1.40
Yes
Hematocrit (L/L)
NM
0.626 ± 0.009
Yes
−0.002 (−0.006, 0.002)
M
0.624 ± 0.008
Yes
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 ()
−0.128 (−0.575, 0.318)
M
52.2 ± 1.64
Yes ()
Hematocrit (L/L)
NM
0.649 ± 0.011
Yes ()
−0.004 (−0.006, 0.002)
M
0.646 ± 0.009
Yes ()
Hemolysis (%): hemoCue/ADVIA
NM
0.162 ± 0.044
Yes ()
0.016 (0.002, 0.029)
M
0.178 ± 0.039
Yes ()
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.