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CompletedNCT02355873Updated May 26, 2021

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

A Phase 4 interventional study of AN69ST hemofilter and AN69 hemofilter in Critical Ill Patients and Patients Needing Continuous Renal Replacement Therapy, sponsored by Peking University First Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-26.

Sponsored by Peking University First Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Critical Ill Patients
  • Patients Needing Continuous Renal Replacement Therapy

Keywords

  • heparin-coated
  • surface-treated polyacrylonitrile membrane hemofilter
  • critical ill
  • acute kidney injury
  • chronic kidney disease
  • continuous renal replacement therapy
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In context

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Care provider, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    AN69ST

    AN69ST:Surface-treated Polyacrylonitrile Membrane Hemofilter

    Device: AN69ST hemofilter

  • Active comparator
    AN69

    AN69:original Polyacrylonitrile Membrane Hemofilter

    Device: AN69 hemofilter

Interventions

  • DeviceAN69ST hemofilter
  • DeviceAN69 hemofilter
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What researchers measure

Primary outcomes

  1. The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process

    Time frame: 6 months

  2. The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter

    Time frame: 6 months

  3. The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading

    Time frame: 6 months

Secondary outcomes

  1. The number of participants with the adverse events.

    Time frame: 6 months

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Study locations

1 site
  • Renal division,department of Medcine,Peking University First Hospital
    Beijing, Beijing 100034, China
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References and documents

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. PubMed 34519356 ↗
  • 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. PubMed 28666474 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02355873
Lead sponsor
Peking University First Hospital
Responsible party
Tao Su (Effect of heparin coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients, Peking University First Hospital) — Principal investigator
First posted
Feb 4, 2015
Start date
Feb 2015
Primary completion
Jul 2015
Completion
Aug 2015
Last update
May 26, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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