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OpenTrials
Completed

NCT Number: NCT02355873

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AN69ST hemofilter

Device

AN69 hemofilter

Device

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

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2015
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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