Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials

Table 6 Adverse events and clinical outcomes in the placebo and rFVIIa groups

All coagulopathic patients	Placebo group (n = 76)	rFVIIa group (n = 60)	P value
Thromboembolic events	3 (4%)	2 (3%)	1.00
Ventilator-free days	21 (0–29)	23 (0–29)	0.4
ICU-free days	12 (0–29)	18 (0–29)	0.3
Critical complication within 30 days
ARDS	9 (12%)	1 (2%)	0.04
MOF	10 (13%)	2 (3%)	0.07
ARDS/MOF	15 (20%)	2 (3%)	0.004
Death	18 (24%)	14 (24%)	1.00
ARDS/MOF/death	25 (33%)	14 (23%)	0.26
Death within 48 hours	10 (13%)	11 (18%)	0.48
Coagulopathic patients surviving more than 48 hours	Placebo group (n = 66)	rFVIIa group (n = 49)	P value
Thromboembolic events	3 (5%)	1 (2%)	0.64
Ventilator-free days	23 (0–29)	25 (0–29)	0.08
ICU-free days	16 (0–29)	20 (0–29)	0.06
Critical complications within 30 days
ARDS	9 (14%)	1 (2%)	0.04
MOF	8 (12%)	1 (2%)	0.08
ARDS/MOF	13 (20%)	1 (2%)	0.004
Death	8 (12%)	3 (6%)	0.4
ARDS/MOF/death	15 (23%)	3 (6%)	0.02

Data are median (range) or number (percentage). ARDS, acute respiratory distress syndrome; ICU, intensive care unit; MOF, multiple organ failure; rFVIIa, recombinant activated factor VII.

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