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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

Page last updated: August 23, 2015

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