A Phase 4 interventional study of Drotrecogin Alfa (Activated) and Unfractionated heparin in Sepsis, sponsored by Eli Lilly and Company. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-01-26.
Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 2,000 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Demonstrate in adult patients with severe sepsis who are receiving drotrecogin alfa (activated) that concomitant treatment with heparin is equivalent to treatment with placebo as determined by 28-day all-cause mortality.
Determine the incidence of venous thrombotic events in patients receiving heparin vs. placebo through study days 6
and 28. Evaluate the safety profile of drotrecogin alfa (activated) and prophylactic heparin co administration by the incidence of intracranial hemorrhage and other serious bleeding events through study day 28.
This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.
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