A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)
Not Applicable
- Conditions
- -A41 Other sepsisOther sepsisA41
- Registration Number
- PER-017-04
- Lead Sponsor
- ELI LILLY INTERAMERICA INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:mortality.<br>Measure: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.<br>Timepoints:28 days<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:incidence of venous thrombotic events<br>Measure:Determine the incidence of venous thrombotic events in patients receiving heparin vs. placebo through study days 6 and 28<br>Timepoints:days 6 and 28<br>