Multi-center Study to Investigate the Effects of Citrasate® on Heparin N Requirements During Hemodialysis Treatment

Completed

Conditions studied: Renal Dialysis

In brief

The purpose of this study is to determine whether the use of Citrasate®, citric acid dialysate enables the reduction of the heparin N (anticoagulant) dose in patients undergoing hemodialysis.

Key facts

Study ID

NCT01092455

Run by

Randolph Quinn

People needed

300

Starts

2009-12-01

Expected to finish

2010-10-01

Last updated by the study team

2011-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is capable of giving informed consent, or has an acceptable surrogate capable of giving consent on the subject's behalf.
• ESRD maintained on thrice weekly HD
• Stable Heparin prescription (Heparin dose) for the previous 4 weeks
• Dialyzed using bolus heparin anticoagulation with dose >/= 2000 units per treatment
• Hgb >/= 9.5 prior to study start
• eKt/V >/= 1.0 (or spKt/V >/= 1.2) in the monthly lab work prior to study start

You may not qualify if…

• Any laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
• Patient is maintained on Coumadin therapy or LMW heparin
• Known history of HIT, coagulopathy or any other bleeding and/or thrombotic disorders
• Patients dialyzed with < 2000 units of Heparin per treatment
• Dialyzed without heparin
• Known pregnancy
• Dialyzed with reuse of hemodialyzers
• Documented clotted dialyzer or dialysis lines in last 30 days (1 month) requiring changing dialyzer, bloodlines or terminating treatment
• Randomized in a clinical trial involving anticoagulation in the last 30 days

Where it is running

• Avantus Renal Therapy-Saint Raphael Dialysis Center — New Haven, Connecticut, United States
• Irving Place Dialysis Center — New York, New York, United States
• Upper Manhattan Dialysis Clinic — New York, New York, United States
• Yorkville Dialysis Center — New York, New York, United States
• DaVita Medical Center Houston — Houston, Texas, United States
• DaVita Rivercenter Dialysis Clinic — San Antonio, Texas, United States
• DaVita Downtown Dialysis Clinic — San Antonio, Texas, United States
• DaVita Northwest Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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