A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

NCT01181544 | Completed

• 1 other identifier: Gambro PI 2012
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure Chronic Requiring Hemodialysis

Keywords

Anticoagulation; Heparin; Hemodialysis; Dialysis; Renal Dialysis

Outcome Measures

Primary Outcomes (1)

• Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm

  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.

  up to 8 weeks

Secondary Outcomes (1)

• Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers

  up to 8 weeks

Study Arms (1)

Heparin dose titration

EXPERIMENTAL

Procedure: Heparin dose titration

Interventions

Heparin dose titration PROCEDURE

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.

Heparin dose titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-compliance with dialysis
• Hematocrit less than 28%
• Active Infection
• Diagnosis of Heparin-Induced Thrombocytopenia (HIT)

Sponsors & Collaborators

• Vantive Health LLC: lead
• University of Louisville: collaborator
• Gambro Renal Products, Inc.: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202-1718, United States

Location

Related Publications (4)

• Farrell PC, Ward RA, Schindhelm K, Gotch F. Precise anticoagulation for routine hemodialysis. J Lab Clin Med. 1978 Aug;92(2):164-76.

  PMID: 681809 BACKGROUND

• 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. doi: 10.1046/j.1525-1594.1998.06101.x.

  PMID: 9754457 BACKGROUND

• Robbins H, Monro S. A stochastic approximation method. Ann Math Stat 22:400-407, 1951.

  BACKGROUND

• Association for the Advancement of Medical Instrumentation: Reuse of Hemodialyzers (ANSI/AAMI RD47:2003). Association for the Advancement of Medical Instrumentation, Arlington, VA, 2003.

  BACKGROUND

Study Officials

• Richard A. Ward, Ph.D.

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 13, 2010
• Study Start: March 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

US (1)