A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

NCT ID: NCT01181544

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heparin dose titration

Group Type: EXPERIMENTAL

Heparin dose titration

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: collaborator

Gambro Renal Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard A. Ward, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Countries

United States

References

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

Reference Type: BACKGROUND

PMID: 681809 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9754457 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

Other Identifiers

Gambro PI 2012

Identifier Type: -

Identifier Source: org_study_id