Sepsis
Conditions
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.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed