Table 1 |
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|
Drotrecogin alfa (activated) clinical trials |
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| Study |
Study type/patients or treatments included |
Number of patients included |
Study period |
Reference |
|
|
||||
| EVAA |
Dose-finding phase II |
131 |
1997 to 1998 |
[10] |
| PROWESS |
Phase III |
1,690 |
1998 to 2000 |
[11] |
| ENHANCE |
Open-label |
2,378 |
2001 to 2003 |
[12] |
| ADDRESS |
Low risk for death |
2,640 |
2002 to 2004 |
[13] |
| RESOLVE |
Sepsis in children |
477 |
2002 to 2005 |
[24] |
| XPRESS |
Heparin + DrotAA |
1,927 |
2003 to 2005 |
[14] |
|
|
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|
ADDRESS, Efficacy and Safety of Drotrecogin alfa [activated] in Adult Severe Sepsis Patients at Low Risk of Death; DrotAA, drotrecogin alfa (activated); ENHANCE, Extended Evaluation of Recombinant Human Activated Protein C, drotrecogin alfa (activated); EVAA, [dose finding study]; 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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Fumagalli and Mignini Critical Care 2007 11(Suppl 5):S6 doi:10.1186/cc6157 |
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