A Trial of Heparin in Patients With Severe Sepsis Who Are Undergoing Treatment With Drotrecogin Alfa (Activated)
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|ClinicalTrials.gov Identifier: NCT00049777|
Recruitment Status : Completed
First Posted : November 15, 2002
Last Update Posted : January 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Drug: Drotrecogin Alfa (Activated) Drug: Unfractionated heparin Drug: Low molecular weight heparin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Study Start Date :||December 2002|
|Study Completion Date :||August 2005|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049777
|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|
|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|