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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
History of Changes
  Purpose

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
Sepsis
 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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049777

Locations
Germany
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
Investigators
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

No publications provided by Eli Lilly and Company

Additional 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:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Protein C
 Drotrecogin alfa activated
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 18, 2013