Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients

Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients Continuous Renal Replacement Therapy Patients

CRRT patients are generally critical ill patients with unstable conditions, such as low blood pressure,severe SIRS,et al. Acute kidney injury(AKI)is especially prevalent,with even two or more organ failure. CRRT serves as an important supportive therapy.Continuous anticoagulation is needed to prevent treatment interruptions due to clotting of the extracorporeal circuit. Unfractionated heparin or low molecular weight heparin both increase the risk of bleeding and heparin induced thrombocytopenia in such cases.However, the problem of CRRT without anticoagulation is the early filter clotting. An alternative method is the use of heparin coated hemofilter. The AN69 ST hemofilter, a surface-treated polyacrylonitrile membrane hemofilter, allows irreversible fixing of heparin to filter membrane, is able to reduce thrombogenic properties of the membrane. In this study, we observe the efficacy and safety of heparin-coated AN69 ST hemofilter in CRRT patients, and compare to the original AN69 membrane hemofilter.

Study Overview

• Status: Completed
• Conditions: Critical Ill Patients; Patients Needing Continuous Renal Replacement Therapy
• Intervention / Treatment: Device: AN69ST hemofilter; Device: AN69 hemofilter

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Renal division,department of Medcine,Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Critical ill patients who need continuous renal replacement therapy
• Continuous anticoagulation therapy is not necessarily during CRRT process

Exclusion Criteria:

• Patients needing continuous anticoagulation during each CRRT process
• Expectant survival time less than 72 hours
• Extremely unstable vital signs such as low blood pressure
• Any reasons that resulting in blood flow rate less than 150ml/min
• Pregnant women
• Patients allergic to heparin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AN69ST; AN69ST:Surface-treated Polyacrylonitrile Membrane Hemofilter	Device: AN69ST hemofilter
Active Comparator: AN69; AN69:original Polyacrylonitrile Membrane Hemofilter	Device: AN69 hemofilter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process	6 months
The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter	6 months
The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of participants with the adverse events.	6 months

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Publications and helpful links

General Publications

• Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
• Su T, Jin Q, Liu Z. Polyethyleneimine-treated polyacrylonitrile membrane hemofilter for critically ill patients receiving anticoagulant-free prolonged intermittent renal replacement therapy: a single-center, prospective, self-controlled pilot study. BMC Nephrol. 2017 Jun 30;18(1):208. doi: 10.1186/s12882-017-0627-1.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Actual): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 22, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: chronic kidney disease; acute kidney injury; continuous renal replacement therapy; critical ill; heparin-coated; surface-treated polyacrylonitrile membrane hemofilter
• Other Study ID Numbers: 2013QX-FZC-001