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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02355873

Enrollment

100

Registered

2015-02-04

Start date

2015-02-28

Completion date

2015-08-31

Last updated

2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DEVICEAN69ST hemofilter

DEVICEAN69 hemofilter

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Intervention model description

ST100 (AN69ST) to M100 (AN69), M100 to ST100

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026