Expired Study
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Washington, District of Columbia 20037


Purpose:

The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).


Study summary:

In United States, there are over 300,000 patients with ESRD who require hemodialysis. Clinical hemodialysis takes place three times a week and is dependent on adequate anticoagulation throughout the three to four hour procedure. Infection is one of the most common causes of death for patients with ESRD treated with hemodialysis (25%). Xigris (drotrecogin alfa activated) is a recombinant form of human activated protein C and is successfully used for treatment of adult patients with severe sepsis. In addition to its fibrinolytic properties, drotrecogin alpha has both an anti-inflammatory effect, and an anti-coagulant effect. However, there are few safety and no efficacy data on the effect of Xigris in ESRD patients as an anticoagulant.


Criteria:

Inclusion Criteria: 1. >18 2. Usually used heparin with HD Exclusion Criteria: 1. Plt <100 2. Pregnancy 3. H/o bleeding diathesis 4. H/o CVA 5. Pt on Ticlid/plavix/warfarin 6. SBP >200 7. BASELINE PTT>50 8. INR>1.6


NCT ID:

NCT01227187


Primary Contact:

Principal Investigator
Lakhmir S Chawla, MD
George Washington University


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20037
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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