A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis
Information source: Gambro Renal Products, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Failure Chronic Requiring Hemodialysis
Intervention: Heparin dose titration (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Gambro Renal Products, Inc. Official(s) and/or principal investigator(s): Richard A. Ward, Ph.D., Principal Investigator, Affiliation: University of Louisville
Summary
During hemodialysis treatments, patients receive heparin to prevent clotting. The purpose
of this pilot study is to determine if the amount of heparin administered during a patient's
hemodialysis can be individualized using an equation for heparin dose adjustment.
Clinical Details
Official title: Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm
Secondary outcome: Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adults 18 years of age or older
- Stable hemodialysis prescription prior to study enrollment
- Dialyzing through a native fistula or Gore-Tex graft
- Blood access must be able to provide a blood flow rate of 400 ml/min
Exclusion Criteria:
- Non-compliance with dialysis
- Hematocrit less than 28%
- Active Infection
- Diagnosis of Heparin-Induced Thrombocytopenia (HIT)
Locations and Contacts
University of Louisville, Louisville, Kentucky 40202-1718, United States
Additional Information
Related publications: Farrell PC, Ward RA, Schindhelm K, Gotch F. Precise anticoagulation for routine hemodialysis. J Lab Clin Med. 1978 Aug;92(2):164-76. Smith BP, Ward RA, Brier ME. Prediction of anticoagulation during hemodialysis by population kinetics and an artificial neural network. Artif Organs. 1998 Sep;22(9):731-9. Robbins H, Monro S. A stochastic approximation method. Ann Math Stat 22:400-407, 1951. Association for the Advancement of Medical Instrumentation: Reuse of Hemodialyzers (ANSI/AAMI RD47:2003). Association for the Advancement of Medical Instrumentation, Arlington, VA, 2003.
Starting date: March 2011
Last updated: January 31, 2012
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