Table 6 |
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|
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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|
Rizoli et al. Critical Care 2006 10:R178 doi:10.1186/cc5133 |
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