A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)

A Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Heparin in Patients With Severe Sepsis and Higher Disease Severity Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)

The purpose of this study is to evaluate the relative efficacy and safety of prophylactic heparin co-administration during drotrecogin alfa (activated) infusion in the treatment of severe sepsis in the adult.

Inclusion Criteria

• Adults greater than or equal to 18 years of age
• Receiving inpatient treatment for severe sepsis
• Indicated for treatment with Drotrecogin Alfa (Activated) under approved label in the country where the patient is enrolled

Exclusion Criteria

• Contraindicated for heparin treatment
• Require a higher dose of heparin than defined in the trial
• Have acute or chronic renal failure with an estimated creatinine clearance less than 30mL/min
• Weigh more than 135 kg (297 pounds)
• Are not expected to survive 28 days given their medical condition.