- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00049777
A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)
January 24, 2007 updated by: Eli Lilly and Company
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
2000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, 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
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Determine the incidence of venous thrombotic events in patients receiving heparin vs. placebo through study days 6
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Study Completion
August 1, 2005
Study Registration Dates
First Submitted
November 13, 2002
First Submitted That Met QC Criteria
November 14, 2002
First Posted (ESTIMATE)
November 15, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
January 26, 2007
Last Update Submitted That Met QC Criteria
January 24, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Sepsis
- Toxemia
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin
- Calcium heparin
- Heparin, Low-Molecular-Weight
- Tinzaparin
- Dalteparin
- Drotrecogin alfa activated
Other Study ID Numbers
- 6743
- F1K-MC-EVBR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Unfractionated heparin
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University of PatrasCompletedCoronary AngiographyGreece
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University of California, Los AngelesCompletedPregnancy Related | Antepartum DVTUnited States
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Beijing Chao Yang HospitalCompletedVascular Diseases | Thrombosis | Thromboembolism | Pulmonary EmbolismChina
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University Hospital, AntwerpUnknownHemodialysis | Acute Kidney InjuryBelgium
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Kristian KarstoftActive, not recruitingBlood Coagulation DisorderDenmark
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Academisch Medisch Centrum - Universiteit van Amsterdam...Dutch Burns FoundationTerminatedBurn Injury | Inhalation InjuryNetherlands, Australia, Belgium
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Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia