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

This study has been completed.

First Received: November 13, 2002 Last Updated: January 24, 2007 History of Changes

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00049777

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Blood Thinners Sepsis

Drug Information available for: Drotrecogin alfa Heparin

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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	6743, F1K-MC-EVBR
Study First Received:	November 13, 2002
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00049777 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Drotrecogin alfa activated
Anticoagulants
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Cardiovascular Agents
Inflammation

Calcium heparin
Calcium, Dietary
Sepsis
Fibrin Modulating Agents
Protein C
Heparin

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Anti-Infective Agents
Drotrecogin alfa activated
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Heparin, Low-Molecular-Weight
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Infection

Pharmacologic Actions
Inflammation
Calcium heparin
Sepsis
Fibrin Modulating Agents
Pathologic Processes
Protein C
Therapeutic Uses
Heparin

ClinicalTrials.gov processed this record on July 02, 2009