Back to resultsA Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)
Primary Purpose
Sepsis
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Drotrecogin Alfa (Activated)
Unfractionated heparin
Low molecular weight heparin
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility Criteria
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.
Sites / Locations
- 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
Outcomes
Primary Outcome Measures
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 Outcome Measures
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.
Full Information
NCT ID
NCT00049777
First Posted
November 13, 2002
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00049777
Brief Title
A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Drotrecogin Alfa (Activated)
Intervention Type
Drug
Intervention Name(s)
Unfractionated heparin
Intervention Type
Drug
Intervention Name(s)
Low molecular weight heparin
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Determine the incidence of venous thrombotic events in patients receiving heparin vs. placebo through study days 6
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Berlin
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17556722
Citation
Levi M, Levy M, Williams MD, Douglas I, Artigas A, Antonelli M, Wyncoll D, Janes J, Booth FV, Wang D, Sundin DP, Macias WL; Xigris and Prophylactic HepaRin Evaluation in Severe Sepsis (XPRESS) Study Group. Prophylactic heparin in patients with severe sepsis treated with drotrecogin alfa (activated). Am J Respir Crit Care Med. 2007 Sep 1;176(5):483-90. doi: 10.1164/rccm.200612-1803OC. Epub 2007 Jun 7.
Results Reference
derived
Learn more about this trial
A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)
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