Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II
| Registry | NCT01181544 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 5 (Actual) |
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| Sponsor | Vantive Health LLC (Industry); collaborators: University of Louisville, Gambro Renal Products, Inc., Baxter Healthcare Corporation |
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| Conditions | Renal Failure Chronic Requiring Hemodialysis |
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| Interventions | Heparin dose titration (Procedure) |
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| Dates | start 2011-03-01, primary completion 2011-08-01, completion 2011-08-01, first posted 2010-08-13, last updated 2025-03-13 |
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| Locations | 1 site in United States |
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Heparin dose titration | Experimental | Procedure: Heparin dose titration | |
- 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.
+Outcome measures
Primary outcomes
- Change in dialyzer blood compartment volume when the heparin dose is adjusted using a Robbins-Monro algorithm [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.
Secondary outcomes
- Evaluation of dialyzer performance and visual assessment of clotting in the fiber bundle and the arterial and venous headers [up to 8 weeks]: Visual assessment of the dialyzer,measurement of ionic dialysance and ionic Kt/V.
+Eligibility
Sex: All, ages: 18 Years to any
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 (1)
| Facility | City | Country | Status |
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| University of Louisville | Louisville, Kentucky | United States | |
+Publications
- 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
- 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
- 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.
+Investigators