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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Calcium heparin; Dalteparin; Drotrecogin alfa activated; Heparin; Heparin, Low-Molecular-Weight; Protein C; Tinzaparin

Criteria

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.