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)

Eli Lilly and Company1 site in 1 country2,000 target enrollmentDecember 2002

ConditionsSepsis

DrugsDrotrecogin Alfa (Activated)Unfractionated heparin Low molecular weight heparin

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Sepsis
Sponsor: Eli Lilly and Company
Enrollment: 2000
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

August 2005

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.