Critical Ill PatientsPhase 4NCT02355873
Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients
A Phase 4 study testing AN69ST hemofilter and AN69 hemofilter in people with Critical Ill Patients and Patients Needing Continuous Renal Replacement Therapy, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Ill Patients, Patients Needing Continuous Renal Replacement Therapy
- What is being tested?
- AN69ST hemofilter and AN69 hemofilter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critical ill patients who need continuous renal replacement therapy
- Continuous anticoagulation therapy is not necessarily during CRRT process
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Renal division,department of Medcine,Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients Continuous Renal Replacement Therapy Patients
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.
- Being tested
- AN69ST hemofilter, AN69 hemofilter
- Keywords
- heparin-coated, surface-treated polyacrylonitrile membrane hemofilter, critical ill, acute kidney injury, chronic kidney disease, continuous renal replacement therapy
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN69ST hemofilterDevice
AN69 hemofilterDevice
| Study group | Role | What they receive |
|---|---|---|
| AN69ST | Experimental | AN69ST:Surface-treated Polyacrylonitrile Membrane Hemofilter Receives: Device: AN69ST hemofilter |
| AN69 | Active comparator | AN69:original Polyacrylonitrile Membrane Hemofilter Receives: Device: AN69 hemofilter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process
Measured: 6 months
The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter
Measured: 6 months
The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading
Measured: 6 months
Secondary outcomes (1)
The number of participants with the adverse events.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical Ill PatientsStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- ST100 (AN69ST) to M100 (AN69), M100 to ST100
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Su, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355873
- Sponsor's protocol ID
- 2013QX-FZC-001
- Status last verified
- May 2021
- First submitted
- 21 Jan 2015
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34519356Su 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.
PubMed 28666474
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in Critical Ill CRRT Patients Continuous Renal Replacement Therapy Patients
- ClinicalTrials.gov ID
- NCT02355873
- Acronym / sponsor ID
- 2013QX-FZC-001
- Keywords
- heparin-coated, surface-treated polyacrylonitrile membrane hemofilter, critical ill, acute kidney injury, chronic kidney disease, continuous renal replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- ST100 (AN69ST) to M100 (AN69), M100 to ST100
| Arm | Type | Receives |
|---|---|---|
| AN69ST | Experimental | Device: AN69ST hemofilterAN69ST:Surface-treated Polyacrylonitrile Membrane Hemofilter |
| AN69 | Active comparator | Device: AN69 hemofilterAN69:original Polyacrylonitrile Membrane Hemofilter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Critical ill patients who need continuous renal replacement therapy
- Continuous anticoagulation therapy is not necessarily during CRRT process
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AN69ST hemofilter | Device | AN69ST |
| AN69 hemofilter | Device | AN69 |
Primary outcome
The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process
Time frame: 6 months
The number of patients with early filter clotting in the scheduled CRRT using AN69ST and AN69 membrane hemofilter
Time frame: 6 months
The number of patients in AN69ST and AN69 hemofilter group according to the final filter clotting grading
Time frame: 6 months
1 secondary outcome
The number of participants with the adverse events.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Derived from this study: PubMed 34519356Tsujimoto 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.
- Derived from this study: PubMed 28666474Su 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AN69ST hemofilter and AN69 hemofilter in people with Critical Ill Patients and Patients Needing Continuous Renal Replacement Therapy, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The filter survival time of AN69ST and AN69 membrane hemofilter in each CRRT process (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355873, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.