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

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

Condition Intervention Phase
Drug: Drotrecogin Alfa (Activated)
Drug: Unfractionated heparin
Drug: Low molecular weight heparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

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.

Estimated Enrollment: 2000
Study Start Date: December 2002
Estimated Study Completion Date: August 2005

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049777

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
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00049777     History of Changes
Other Study ID Numbers: 6743  F1K-MC-EVBR 
Study First Received: November 13, 2002
Last Updated: January 24, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pathologic Processes
Systemic Inflammatory Response Syndrome
Calcium heparin
Drotrecogin alfa activated
Heparin, Low-Molecular-Weight
Protein C
Anti-Infective Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016