Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia

Table 3 Primary and secondary endpoints

End point	Arm A: 20 ml/kg (N = 82)	Arm B: 30 ml/kg (N = 78)	Risk ratio (95% CI)	Pvalue
Time to correction of severe anemia (by 24 hours) - number (%)	61 (74)	70 (90)	1.54^a (1.09,2.18)	0.01
Children meeting the criteria for additional transfusion - number (%)	12 (15)	4(5)	0.35 (0.12, 1.04)	0.06
SAE – number (%)	6 (7)	2 (3)	0.35 (0.07, 1.68)	0.28
Died before 48 hours – number (%)	4 (5)	0 (0)		0.12
Died before 28 days post-admission – number (%)	6 (7)	1 (1)	0.18 (0.02, 1.42)	0.12
Severe anemia or mortality at 28 days – number/total n^b (%)	9/76 (12)	4/72 (6)	0.47 (0.15, 1.46)	0.25

^acause specific hazard ratio for correction of severe anemia before death (results similar using competing risks sub-distribution hazard, not shown); ^bdenominator excludes children who were alive at 28 days but in whom hemoglobin was not measured. CI, confidence interval; SAE, serious adverse event.

ISSN: 1741-7015