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

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ClinicalTrials.gov Identifier: NCT02355873
Recruitment Status : Unknown
Verified February 2015 by Tao Su, Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : February 4, 2015
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Tao Su, 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.

Condition or disease Intervention/treatment Phase
Critical Ill Patients Patients Needing Continuous Renal Replacement Therapy Device: AN69ST hemofilter Device: AN69 hemofilter Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients Continuous Renal Replacement Therapy Patients
Study Start Date : February 2015
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: AN69ST
AN69ST:Surface-treated Polyacrylonitrile Membrane Hemofilter
Device: AN69ST hemofilter
Active Comparator: AN69
AN69:original Polyacrylonitrile Membrane Hemofilter
Device: AN69 hemofilter



Primary Outcome Measures :
  1. The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process [ Time Frame: 6 months ]
  2. The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter [ Time Frame: 6 months ]
  3. The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The number of participants with the adverse events. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355873


Contacts
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Contact: Tao Su, MD 861083575755 tao.su@bjmu.edu.cn

Locations
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China, Beijing
Renal division,department of Medcine,Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Tao Su, MD    +861083575755    tao.su@bjmu.edu.cn   
Contact: Qizhuang Jin, MD    +861083575687    jinqizhuang@medmail.com.cn   
Principal Investigator: Tao Su, MD         
Sub-Investigator: Qizhuang Jin, MD         
Sponsors and Collaborators
Peking University First Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tao Su, Effect of heparin coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02355873     History of Changes
Other Study ID Numbers: 2013QX-FZC-001
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: February 2015
Keywords provided by Tao Su, Peking University First Hospital:
heparin-coated
surface-treated polyacrylonitrile membrane hemofilter
critical ill
acute kidney injury
chronic kidney disease
continuous renal replacement therapy
Additional relevant MeSH terms:
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Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action