Table 2. Primary, Secondary, and Other Outcomes* .
| Outcome | Higher Volume: 30 ml/kg (N = 1598) | Lower Volume: 20 ml/kg (N = 1598) | Total (N = 3196) | Hazard Ratio (95% Cl)† | P Value |
|---|---|---|---|---|---|
| Death — no. (%) | |||||
| At 48 hr‡ | 32 (2.0) | 34(2.1) | 66 (2.1) | 0.94 (0.58–1.52) | |
| At 28 days: primary outcome | 55 (3.4) | 72 (4.5) | 127 (4.0) | 0.76 (0.54–1.08) | 0.12 |
| At 90 days‡ | 93 (5.8) | 114(7.1) | 207 (6.5) | 0.81 (0.61–1.06) | |
| At 180 days‡ | 134 (8.4) | 154 (9.6) | 288 (9.0) | 0.86 (0.68–1.08) | |
| Correction of anemia during the primary hospitalization — no. (%)‡ | 678 (42.4) | 349 (21.8) | 1027 (32.1) | 2.13 (1.89–2.41)§ | |
| Development of new profound anemia during the primary hospitalization— no.(%)‡ | 40 (2.5) | 85 (5.3) | 125 (3.9) | 0.47 (0.32–0.68)§ | |
| Development of severe anemia after discharge — no. (%)‡ | 338 (21.2) | 303 (19.0) | 641 (20.1) | 1.10 (0.94–1.28)§ | |
| Readmission to hospital — no. (%)‡ | 301 (18.8) | 278 (17.4) | 579 (18.1) | 1.08 (0.92—1.27)§ | |
| Serious adverse event | |||||
| At least one event — no. of patients (%)‡ | 431 (27.0) | 416 (26.0) | 847 (26.5) | 1.03 (0.90–1.18) | 0.63 |
| No. of events | 608 | 544 | 1152 | ||
| Type of serious adverse event | |||||
| Anemia¶ | |||||
| At least one event — no. of patients (%) | 230 (14.4) | 224 (14.0) | 454 (14.2) | 0.80‖ | |
| No. of events | 323 | 292 | 615 | ||
| Malaria | |||||
| At least one event — no. of patients (%) | 129 (8.1) | 108 (6.8) | 237 (7.4) | 0.18‖ | |
| No. of events | 149 | 119 | 268 | ||
| Sepsis | |||||
| At least one event — no. of patients (%) | 67 (4.2) | 78 (4.9) | 145 (4.5) | 0.40‖ | |
| No. of events | 85 | 95 | 180 | ||
| Hemoglobinuria | |||||
| At least one event — no. of patients (%) | 52 (3.3) | 44 (2.8) | 96 (3.0) | 0.3 9‖ | |
| No. of events | 64 | 51 | 115 | ||
| Suspected allergic reaction — no. (%)‡ ** | 25 (1.6) | 20 (1.3) | 45 (1.4) | 0.55‖ | |
| Suspected transfusion-related lung injury— no. (%)‡ ** | 2 (0.1) | 3 (0.2) | 5 (0.2) | 1.00‖ | |
| Suspected raised intracranial pressure — no. (%)** | 1 (0.1) | 0 | 1 (<0.1) |
Correction of anemia was defined as a hemoglobin level of more than 9 g per deciliter. Profound anemia was defined as a hemoglobin level of less than 4 g per deciliter. Severe anemia was defined as a hemoglobin level of less than 6 g per deciliter. Suspected transfusion-related lung injury refers to suspected pulmonary overload, transfusion-related acute lung injury, or transfusion-related cardiac overload. CI denotes confidence interval.
Hazard ratios are for the higher-volume group as compared with the lower-volume group. Confidence intervals have not been adjusted for multiple testing, and inferences drawn from the intervals may not be reproducible.
This is a secondary outcome that was prespecified in the protocol. The P value is not reported except for adverse events.
This hazard ratio was estimated from competing-risks subhazard regression.
The diagnosis of the serious adverse event of anemia (including anemia-related death) was made by the attending clinician (during the primary hospitalization and after discharge). There was no formal hemoglobin threshold required.
This P value was calculated with Fisher’s exact test.
Grades of adverse events are shown in Table S9 in the Supplementary Appendix.