Status:
COMPLETED
Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion
Lead Sponsor:
Eli Lilly and Company
Conditions:
Sepsis
Hypotension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether continued administration of Drotrecogin Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in...
Eligibility Criteria
Inclusion
- Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
- Continue requirement of Vasopressor support after 96 hour commercial infusion
Exclusion
- Patients require extensive surgical procedures within next 3 days
- Patients with platelet count below 30,000/mm3
- Patients receiving therapeutic heparin of 15,000 units/day and more
- Patients not expected to survive 24 days
- Patients contraindicated as to the country specific registration
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00190788
Start Date
June 1 2004
End Date
May 1 2007
Last Update
October 12 2007
Active Locations (2)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Loma Linda, California, United States, 92350
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paris, France, 75679