A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

• ClinicalTrials.gov Identifier: NCT01181544
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Last Update Posted: May 8, 2017
• Sponsor: Baxter Healthcare Corporation
• Collaborators: University of Louisville; Gambro Renal Products, Inc.
• Information provided by (Responsible Party): Baxter Healthcare Corporation

Tracking Information

• First Submitted Date: August 11, 2010
• First Posted Date: August 13, 2010
• Last Update Posted Date: May 8, 2017
• Study Start Date: March 2011
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2010)

Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm [ Time Frame: up to 8 weeks ]

The objective is to titrate each patient's heparin dose to the level that achieves adequate anticoagulation for that patient as assessed by the change in blood compartment volume of the dialyzer from pre- to post-dialysis. The strategy that will be used is the Robbins-Monro stochastic approximation algorithm.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 11, 2010)

Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers [ Time Frame: up to 8 weeks ]

Visual assessment of the dialyzer,measurement of ionic dialysance and ionic Kt/V.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis
• Official Title: Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Renal Failure Chronic Requiring Hemodialysis

Intervention

Procedure: Heparin dose titration

Patients will begin the study using their currently prescribed heparin doses - both bolus and constant infusion - for three treatments to establish a baseline and provide information on inter-treatment variability in dialyzer clotting. Subsequently, the bolus and infusion rates will be titrated either upward or downward based on the Robbins-Monro process and an evaluation of dialyzer clotting during the preceding treatment. Heparin doses will be adjusted for a total of 30 dialyses.

Study Arms

Experimental: Heparin dose titration

Intervention: Procedure: Heparin dose titration

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2010): 5
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01181544
• Other Study ID Numbers: Gambro PI 2012
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Baxter Healthcare Corporation
• Study Sponsor: Baxter Healthcare Corporation

Collaborators

• University of Louisville
• Gambro Renal Products, Inc.

Investigators

• Principal Investigator: Richard A. Ward, Ph.D.; University of Louisville

• PRS Account: Baxter Healthcare Corporation
• Verification Date: May 2017