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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Randolph Quinn
• Treatments: Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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