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

Phase 4

Completed

• Conditions: Patients Needing Continuous Renal Replacement Therapy; Critical Ill Patients
• Interventions: Device: AN69ST hemofilter; Device: AN69 hemofilter

• Registration Number: NCT02355873
• Lead Sponsor: Peking University First Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-30
• Study Start: 2015-02
• Study First Posted: 2015-02-04
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-22
• Last Update Posted: 2021-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AN69ST	AN69ST hemofilter	AN69ST:Surface-treated Polyacrylonitrile Membrane Hemofilter
AN69	AN69 hemofilter	AN69:original Polyacrylonitrile Membrane Hemofilter

Primary Outcome Measures

Name	Time	Method
The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading	6 months
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

Secondary Outcome Measures

Name	Time	Method
The number of participants with the adverse events.	6 months

Trial Locations

Locations (1)

Renal division,department of Medcine,Peking University First Hospital; 🇨🇳 Beijing, Beijing, China