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

Eli Lilly and Company2,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,000

Conditions

Sepsis

Interventions

Drotrecogin Alfa (Activated)DRUG

Unfractionated heparinDRUG

Low molecular weight heparinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician

Berlin, Germany

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.

Data from ClinicalTrials.gov

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