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

Peking University

Status and phase: Completed; Phase 4

Conditions: Critical Ill Patients; Patients Needing Continuous Renal Replacement Therapy

Treatments: Device: AN69ST hemofilter; Device: AN69 hemofilter

Study type: Interventional

Funder types: Other

Identifiers

NCT02355873

2013QX-FZC-001

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups

AN69ST

Experimental group

Description:

AN69ST:Surface-treated Polyacrylonitrile Membrane Hemofilter

Treatment:

Device: AN69ST hemofilter

AN69

Active Comparator group

Description:

AN69:original Polyacrylonitrile Membrane Hemofilter

Treatment:

Device: AN69 hemofilter