NCT00049777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_4 sepsis

Timeline
Completed

Started Dec 2002

Typical duration for phase_4 sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2002

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2002

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

November 13, 2002

Last Update Submit

January 24, 2007

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

Interventions

Drotrecogin Alfa (Activated)DRUG
Unfractionated heparinDRUG
Low molecular weight heparinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

Related Publications (1)

  • 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.

    PMID: 17556722DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

drotrecogin alfa activatedHeparinHeparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 13, 2002

First Posted

November 15, 2002

Study Start

December 1, 2002

Study Completion

August 1, 2005

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

DE(1)