Adult Chronic Haemodialysis Patients Since at Least 3 MonthsNCT01221337
Heparin Free Haemodialysis With Haemodialyzers "VIE" Versus "EVODIAL"
A study testing heparin free haemodialysis in people with Adult Chronic Haemodialysis Patients Since at Least 3 Months, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy during a haemodialysis session. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Chronic Haemodialysis Patients Since at Least 3 Months
- What is being tested?
- heparin free haemodialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2010to Feb 2011
- Phase
- Interventional
- 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
- -- Adult chronic haemodialysis patients since al least 3 months
- Two needles puncture of the fistula,
- Low molecular weight heparinization during haemodialysis sessions,
- Good fistula or central veinous catheter flow rate (blood pump flow rate ≥ 300 ml/min),
- Systolic blood pressure ≥ 110 mmHg (mean value of three last dialysis sessions.
- Patients capable to understand the design of the study and to follow the instructions
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- Patients having the French social security system affiliation.
- Non-inclusion criteria :
- C reactive protein > 30 mg/L.
- Single needle puncture of the fistula
- Active documented haemorrhage,
- Haemoglobin < 10 g/dl and/or need blood transfusion,
- Documented thrombophilia
- Patients waiting for renal graft
- Acute sepsis
- Fistula or catheter dysfunction
- Patients under anti-vitamine K
- Per dialytic hypotension requiring al least once a nurse intervention,
- Severe diseases (Dysglobulinemia, vascularitis, HIV…),
- Patients following another research protocol or have ended one less then one month before starting of this study.
- Pregnant or breast feeding patients,
- Minor patients or under law-protection
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Comparative Study of Two Haemodialyzers "VIE 2.1" Versus "EVODIAL2.2" in a Strategy of Heparin-free Haemodialysis (HFH)
The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy during a haemodialysis session. In the cases of multiple coagulation defects having high haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low heparin or heparin free haemodialysis have been proposed till now, without a real success. The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 % successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic properties and a capacity to improve the haemorrheological factors of human blood, hence having a promising future to perform a successful haemodialysis session with less or without heparin. This randomised, multi-centric, cross-over and open study has been designed to compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of 5% and an absolute accepted difference of 12 %.
- Being tested
- heparin free haemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin free haemodialysisOther
Comparison of two haemodialyzers "VIE 2,1" versus "EVODIAL 2,2" in a strategy of heparin-free haemodialysis (HFH).
| Study group | Role | What they receive |
|---|---|---|
| haemodialyzer EVODIAL-haemodialyzer VIE | Other | Equal number of patients will start either with the haemodialyzer "VIE 2,1" or "EVODIAL 2,2" followed by a wash out period, before starting the other haemodialyzer. Receives: Other: heparin free haemodialysis |
| haemodialyzer VIE-haemodialyzer Evodial | Other | Equal number of patients will start either with the haemodialyzer "VIE 2,1" or "EVODIAL 2,2" followed by a wash out period, before starting the other haemodialyzer. Receives: Other: heparin free haemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of successful study periods with no circuit-clotting event leading to a premature interruption of any of the four dialysis sessions
Measured: during every haemodialysis sessions
Secondary outcomes (7)
Duration of dialysis session without blood circuit clotting
Measured: during every haemodialysis sessions
Number of times saline rinsing has been required
Measured: during every haemodialysis
Degree of blood clots in the venous bubble trap
Measured: during every haemodialysis sessions
Quality of blood restitution
Measured: during every haemodialysis sessions
Dialysis adequacy (KT/V)
Measured: during every haemodialysis sessions
Haematological status
Measured: during every haemodialysis sessions
tolerance
Measured: during every haemodialysis sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Chronic Haemodialysis Patients Since at Least 3 MonthsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Shariful ISLAM, PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221337
- Sponsor's protocol ID
- 10-PP-09
- Status last verified
- Jun 2016
- First submitted
- 14 Oct 2010
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Haemodialyzers "VIE 2.1" Versus "EVODIAL2.2" in a Strategy of Heparin-free Haemodialysis (HFH)
- ClinicalTrials.gov ID
- NCT01221337
- Acronym / sponsor ID
- 10-PP-09
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Oct 2010 (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.
The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy during a haemodialysis session. In the cases of multiple coagulation defects having high haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low heparin or heparin free haemodialysis have been proposed till now, without a real success. The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 % successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic properties and a capacity to improve the haemorrheological factors of human blood, hence having a promising future to perform a successful haemodialysis session with less or without heparin. This randomised, multi-centric, cross-over and open study has been designed to compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of 5% and an absolute accepted difference of 12 %.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| haemodialyzer EVODIAL-haemodialyzer VIE | Other | Other: heparin free haemodialysisEqual number of patients will start either with the haemodialyzer "VIE 2,1" or "EVODIAL 2,2" followed by a wash out period, before starting the other haemodialyzer. |
| haemodialyzer VIE-haemodialyzer Evodial | Other | Other: heparin free haemodialysisEqual number of patients will start either with the haemodialyzer "VIE 2,1" or "EVODIAL 2,2" followed by a wash out period, before starting the other haemodialyzer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- -- Adult chronic haemodialysis patients since al least 3 months
- Two needles puncture of the fistula,
- Low molecular weight heparinization during haemodialysis sessions,
- Good fistula or central veinous catheter flow rate (blood pump flow rate ≥ 300 ml/min),
- Systolic blood pressure ≥ 110 mmHg (mean value of three last dialysis sessions.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| heparin free haemodialysisComparison of two haemodialyzers "VIE 2,1" versus "EVODIAL 2,2" in a strategy of heparin-free haemodialysis (HFH). | Other | haemodialyzer EVODIAL-haemodialyzer VIE, haemodialyzer VIE-haemodialyzer Evodial |
Primary outcome
The percentage of successful study periods with no circuit-clotting event leading to a premature interruption of any of the four dialysis sessions
Time frame: during every haemodialysis sessions
7 secondary outcomes
Duration of dialysis session without blood circuit clotting
Time frame: during every haemodialysis sessions
Number of times saline rinsing has been required
Time frame: during every haemodialysis
Degree of blood clots in the venous bubble trap
Time frame: during every haemodialysis sessions
Quality of blood restitution
Time frame: during every haemodialysis sessions
Dialysis adequacy (KT/V)
Time frame: during every haemodialysis sessions
Haematological status
Time frame: during every haemodialysis sessions
tolerance
Time frame: during every haemodialysis sessions
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 13 Jun 2016.
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.
Mohamed Shariful ISLAM, PH principal investigator
Centre Hospitalier Universitaire de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heparin free haemodialysis in people with Adult Chronic Haemodialysis Patients Since at Least 3 Months, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 22 inclusion and 0 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 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
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 percentage of successful study periods with no circuit-clotting event leading to a premature interruption of any of the four dialysis sessions (time frame: during every haemodialysis sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2016.