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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00049777 |
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 |
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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) |
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
Exclusion Criteria
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 |
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 |
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 |
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 |
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 |