Adjusted mean (95% CIs) clinical laboratory values measured at 2 hours, 24 hours, and 2 weeks after transfusion across transfusion visits 1 to 3, adjusting for pretransfusion value, number of units transfused, transfusion number, and phlebotomy time point, using linear mixed models
| Laboratory test result . | ≤10-day arm . | ≥30-day arm . | ITT P value . | On-protocol P value . |
|---|---|---|---|---|
| HbA, % | 70.38 (63.20-72.55) | 70.24 (67.93-72.55) | .9 | .6 |
| HbA, g/dL | 6.46 (6.11-6.82) | 6.96 (6.59-7.33) | .06 | .05 |
| Hb, g/dL | 9.49 (9.02-9.96) | 9.71 (9.23-10.19) | .5 | .3 |
| WBC, cells per μL | 11.60 (10.94-12.25) | 11.37 (10.58-12.15) | .7 | .6 |
| RBC, million per μL | 3.20 (3.04-3.37) | 3.29 (3.12-3.46) | .5 | .2 |
| Hematocrit, % | 28.70 (27.45-29.95) | 29.04 (27.75-30.32) | .7 | .8 |
| MCV, fL | 88.86 (87.92-89.80) | 87.88 (86.89-88.87) | .15 | .07 |
| MCH, pg per cell | 29.74 (29.49-29.99) | 29.64 (29.36-29.92) | .05 | .9 |
| MCHC, g/dL | 33.39 (33.12-33.66) | 33.80 (33.50-34.09) | .04 | .2 |
| RDW, % | 19.55 (19.11-19.99) | 19.42 (18.95-19.90) | .7 | .8 |
| Platelet count, /μL | 352.55 (327.84-377.22) | 352.07 (326.04-378.09) | .9 | .9 |
| Neutrophils, % | 52.26 (48.72-55.79) | 55.55 (51.77-59.32) | .2 | .5 |
| Lymphocytes, % | 32.04 (28.60-35.48) | 30.07 (26.46-33.68) | .4 | .6 |
| Monocytes, % | 11.29 (10.39-12.20) | 9.64 (8.59-10.68) | .02 | .03 |
| Eosinophils, % | 3.82 (3.33-4.31) | 3.06 (2.51-3.62) | .05 | .4 |
| Basophils, % | 0.83 (0.62-1.04) | 0.81 (0.58-104) | .9 | .7 |
| Sodium, mEq/L | 139.79 (139.11-140.48) | 138.82 (138.03-139.62) | .07 | .05 |
| Potassium, mEq/L | 4.39 (4.23-4.56) | 4.78 (4.57-4.98) | .007 | .007 |
| Chloride, mEq/L | 104.29 (103.77-104.81) | 103.66 (103.04-104.28) | .1 | .1 |
| Bicarbonate, mEq/L | 22.35 (21.78-22.91) | 20.80 (20.08-21.53) | .002 | .002 |
| Glucose, mg/dL | 90.73 (78.78-102.69) | 95.24 (81.33-109.16) | .6 | .6 |
| BUN, mg/dL | 19.28 (18.45-20.11) | 19.42 (18.31-20.54) | .8 | .8 |
| Creatinine, mg/dL | 1.60 (–0.15 to 3.34) | 1.99 (0.05-3.94) | .8 | .8 |
| LDH, U/L | 474.28 (458.07-490.48) | 497.78 (478.56-517.00) | .06 | .2 |
| Serum Iron, μg/dL | 114.18 (103.53-124.83) | 155.37 (142.04-168.69) | <.0001 | <.0001 |
| Transferrin saturation, % | 42.35 (36.67-48.73) | 62.05 (50.67-71.89) | .006 | .007 |
| Ferritin, ng/mL | 4308.77 (4048.89-4568.65) | 4437.49 (4101.54-4773.44) | .6 | .2 |
| TIBC, μg/dL | 218.53 (208.29-228.76) | 216.75 (197.89-235.60) | .9 | .9 |
| CRP, mg/L | 10.94 (9.10-13.21) | 12.63 (10.14-14.99) | .3 | .4 |
| Plasma Hb, mg/dL | 6.71 (–2.02 to 15.45) | 10.93 (0.17-21.68) | .5 | .7 |
| Laboratory test result . | ≤10-day arm . | ≥30-day arm . | ITT P value . | On-protocol P value . |
|---|---|---|---|---|
| HbA, % | 70.38 (63.20-72.55) | 70.24 (67.93-72.55) | .9 | .6 |
| HbA, g/dL | 6.46 (6.11-6.82) | 6.96 (6.59-7.33) | .06 | .05 |
| Hb, g/dL | 9.49 (9.02-9.96) | 9.71 (9.23-10.19) | .5 | .3 |
| WBC, cells per μL | 11.60 (10.94-12.25) | 11.37 (10.58-12.15) | .7 | .6 |
| RBC, million per μL | 3.20 (3.04-3.37) | 3.29 (3.12-3.46) | .5 | .2 |
| Hematocrit, % | 28.70 (27.45-29.95) | 29.04 (27.75-30.32) | .7 | .8 |
| MCV, fL | 88.86 (87.92-89.80) | 87.88 (86.89-88.87) | .15 | .07 |
| MCH, pg per cell | 29.74 (29.49-29.99) | 29.64 (29.36-29.92) | .05 | .9 |
| MCHC, g/dL | 33.39 (33.12-33.66) | 33.80 (33.50-34.09) | .04 | .2 |
| RDW, % | 19.55 (19.11-19.99) | 19.42 (18.95-19.90) | .7 | .8 |
| Platelet count, /μL | 352.55 (327.84-377.22) | 352.07 (326.04-378.09) | .9 | .9 |
| Neutrophils, % | 52.26 (48.72-55.79) | 55.55 (51.77-59.32) | .2 | .5 |
| Lymphocytes, % | 32.04 (28.60-35.48) | 30.07 (26.46-33.68) | .4 | .6 |
| Monocytes, % | 11.29 (10.39-12.20) | 9.64 (8.59-10.68) | .02 | .03 |
| Eosinophils, % | 3.82 (3.33-4.31) | 3.06 (2.51-3.62) | .05 | .4 |
| Basophils, % | 0.83 (0.62-1.04) | 0.81 (0.58-104) | .9 | .7 |
| Sodium, mEq/L | 139.79 (139.11-140.48) | 138.82 (138.03-139.62) | .07 | .05 |
| Potassium, mEq/L | 4.39 (4.23-4.56) | 4.78 (4.57-4.98) | .007 | .007 |
| Chloride, mEq/L | 104.29 (103.77-104.81) | 103.66 (103.04-104.28) | .1 | .1 |
| Bicarbonate, mEq/L | 22.35 (21.78-22.91) | 20.80 (20.08-21.53) | .002 | .002 |
| Glucose, mg/dL | 90.73 (78.78-102.69) | 95.24 (81.33-109.16) | .6 | .6 |
| BUN, mg/dL | 19.28 (18.45-20.11) | 19.42 (18.31-20.54) | .8 | .8 |
| Creatinine, mg/dL | 1.60 (–0.15 to 3.34) | 1.99 (0.05-3.94) | .8 | .8 |
| LDH, U/L | 474.28 (458.07-490.48) | 497.78 (478.56-517.00) | .06 | .2 |
| Serum Iron, μg/dL | 114.18 (103.53-124.83) | 155.37 (142.04-168.69) | <.0001 | <.0001 |
| Transferrin saturation, % | 42.35 (36.67-48.73) | 62.05 (50.67-71.89) | .006 | .007 |
| Ferritin, ng/mL | 4308.77 (4048.89-4568.65) | 4437.49 (4101.54-4773.44) | .6 | .2 |
| TIBC, μg/dL | 218.53 (208.29-228.76) | 216.75 (197.89-235.60) | .9 | .9 |
| CRP, mg/L | 10.94 (9.10-13.21) | 12.63 (10.14-14.99) | .3 | .4 |
| Plasma Hb, mg/dL | 6.71 (–2.02 to 15.45) | 10.93 (0.17-21.68) | .5 | .7 |
The on-protocol P value excluded the 12 transfusion visits from 8 patients who did not receive the per-protocol storage age allocation. Significant differences noted between the 2 study arms included monocytes, potassium, bicarbonate, serum iron, and transferrin saturation.
BUN, blood urea nitrogen; CRP, C-reactive protein; LDH, lactate dehydrogenase; MCH, mean corpuscular hemoglobin; MCHC, mean corpuscular hemoglobin concentration; MCV, mean corpuscular volume; TIBC, total iron-binding capacity.