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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00049777
First received: November 13, 2002
Last updated: January 24, 2007
Last verified: January 2007

November 13, 2002
January 24, 2007
December 2002
Not Provided
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.
Not Provided
Complete list of historical versions of study NCT00049777 on ClinicalTrials.gov Archive Site
  • 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.
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A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Sepsis
  • Drug: Drotrecogin Alfa (Activated)
  • Drug: Unfractionated heparin
  • Drug: Low molecular weight heparin
Not Provided
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. Epub 2007 Jun 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
August 2005
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00049777
6743, F1K-MC-EVBR
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP