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

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

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
  1. 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.