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Table 2 Bleeding events for the 28-day study (period) in clinical trials evaluating DrotAA in severe sepsis

From: Clinical trials in severe sepsis with drotrecogin alfa (activated)

 

All bleeding events (%)

Serious bleeding events (%)

CNS bleeding (%)

Study

DrotAA

Placebo

P

DrotAA

Placebo

P

DrotAA

Placebo

P

Adults

         

   Phase II [1]

ND

ND

 

4.0

5.0

0.99

0

0

NS

   PROWESS [2]

ND

ND

 

3.5

2.0

0.06

0.2

0

NS

   ENHANCE [11]

ND

NA

 

6.5

NA

 

1.5

NA

NA

   ADDRESS [12]

ND

ND

 

3.9

2.2

0.01

0.5

0.4

NS

   XPRESS [13]a

12.4

10.9

0.32

3.9

5.2

0.16

1.0

0.7

0.49

Children

         

   Phase Ib [14]

20.5

NA

 

4.8

NA

 

2.4

NA

NA

   RESOLVE [15]

ND

ND

 

6.7

6.8

0.97

4.6

2.1

0.13

  1. aFor the XPRESS trial all patients received drotecogin alfa (activated; DrotAA). Placebo refers to absence of concomitant heparin prophylaxis during DrotAA infusion. ADDRESS, Administration of Drotrecogin alfa (activated) in early stage Severe Sepsis; ENHANCE, Extended Evaluation of Recombinant Human Activated Protein C; NA, not applicable; ND, not described; PROWESS, Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis; RESOLVE, REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective; XPRESS, Xigris and Prophylactic hepaRin Evaluation in Severe Sepsis.
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