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

Study Overview
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Brief Summary
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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.

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

Conditions
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Critical Ill Patients, Patients Needing Continuous Renal Replacement Therapy

Intervention / Treatment
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* Device: AN69ST hemofilter
* Device: AN69 hemofilter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: ST100 (AN69ST) to M100 (AN69), M100 to ST100
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AN69ST<br>AN69ST:Surface-treated Polyacrylonitrile Membrane Hemofilter | Device: AN69ST hemofilter<br> <br> |
| Active Comparator: AN69<br>AN69:original Polyacrylonitrile Membrane Hemofilter | Device: AN69 hemofilter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with the adverse events. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin-coated, surface-treated polyacrylonitrile membrane hemofilter, critical ill, acute kidney injury, chronic kidney disease, continuous renal replacement therapy