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

NCT02355873 | Completed Phase 4

• 1 other identifier: 2013QX-FZC-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The number of participants with the adverse events.

  6 months

Study Arms (2)

AN69ST

EXPERIMENTAL

AN69ST:Surface-treated Polyacrylonitrile Membrane Hemofilter

Device: AN69ST hemofilter

AN69

ACTIVE COMPARATOR

AN69:original Polyacrylonitrile Membrane Hemofilter

Device: AN69 hemofilter

Interventions

AN69ST hemofilter DEVICE

AN69ST

AN69 hemofilter DEVICE

AN69

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critical ill patients who need continuous renal replacement therapy
• Continuous anticoagulation therapy is not necessarily during CRRT process

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Renal division,department of Medcine,Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (2)

• Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.

  PMID: 34519356 DERIVED

• Su T, Jin Q, Liu Z. Polyethyleneimine-treated polyacrylonitrile membrane hemofilter for critically ill patients receiving anticoagulant-free prolonged intermittent renal replacement therapy: a single-center, prospective, self-controlled pilot study. BMC Nephrol. 2017 Jun 30;18(1):208. doi: 10.1186/s12882-017-0627-1.

  PMID: 28666474 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of heparin coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients

Model Details: ST100 (AN69ST) to M100 (AN69), M100 to ST100

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 4, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

CN (1)