Chronic Kidney FailureNCT00804453
Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line
A study testing Cartridge blood set and Standard blood line in people with Chronic Kidney Failure, run by Vantive Health LLC at 1 site in France.
Trial summary
The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- Cartridge blood set and Standard blood line
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Nov 2008
- 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
- Patients suffering from chronic renal failure,
- Patients treated in HD performed with or without heparin injection in the extra corporeal circuit (ECC) irrespective the type of heparin (UFH and LMWH),
- Patients treated three times a week for a minimum of three (3) months,
- Patients 18 years or older,
- Patients with a well-functioning vascular access as judged by the investigator,
- Patients with negative serologies (HIV, hepatitis),
- Patients having signed written informed consent to participate in the study.
Who cannot join
- Patients with known allergy to heparin,
- Patients with acute inflammatory event that may affect, as judged by the investigator, the results of the study or the safety of the patients,
- Active malignant disease,
- Pregnant women, nursing mothers and women planning a pregnancy during the course of the study,
- Patients under guardianship,
- Patients participating in other studies that could interfere with the objectives of this study,
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- Patients treated in single needle mode,
- Patients with catheter,
- Patients receiving Anti-Vit K drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line: A Pilot Monocentric Open Randomized and Cross-over Study.
The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.
Read the detailed description
Interactions between blood components (cells and proteins) and the extracorporeal circuit induce the activation of several biological systems such as platelets, complement and coagulation cascades. The coagulation system generates a key enzyme, factor IIa or thrombin, responsible for blood clotting in the dialysis circuit Because clotting in the circuit may reduce the dialysis efficiency, the anticoagulation of the extracorporeal circuit is needed .
For several years, most of the researches were mainly focused on the improvement of the biocompatibility of dialysis membranes .
The contribution of the various components of the dialysis circuit on the coagulation activation has not been clearly established.
A circuit integrating a cartridge blood set is commercialised for several years. The design of this cartridge blood set reduces the surface in contact with blood and minimizes the blood air interface which are well known sources of coagulation activation.
The aim of this study is to collect data to evaluate the biocompatibility of two types of blood circuit (cartridge blood set vs standard blood line).
- Conditions
- Chronic Kidney Failure
- Being tested
- Cartridge blood set, Standard blood line
- Keywords
- Chronic Kidney Failure, Hemodialysis, Biocompatibility
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartridge blood setDevice
Once a week
Standard blood lineDevice
Once a week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard blood line Receives: Device: Standard blood line |
| 2 | Experimental | Cartridge blood line Receives: Device: Cartridge blood set |
What is being measured
The primary outcome is the main question the study is designed to answer.
The biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation.
Measured: During dialysis treatment
Secondary outcomes (1)
The quality of the restitution of both the filter and the circuit, at the end of each treatment, will be evaluated via visual scales.
Measured: End of dialysis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Lundia AB, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Walid Arkouche, Dr, Principal investigator, AURAL dialysis centre Lyon France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804453
- Sponsor's protocol ID
- 1455
- Other IDs
- ISRCTN15261860
- Status last verified
- Mar 2025
- First submitted
- 5 Dec 2008
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lucchi L, Ligabue G, Marietta M, Delnevo A, Malagoli M, Perrone S, Stipo L, Grandi F, Albertazzi A. Activation of coagulation during hemodialysis: effect of blood lines alone and whole extracorporeal circuit. Artif Organs. 2006 Feb;30(2):106-10. doi: 10.1111/j.1525-1594.2006.00188.x.
PubMed 16433843
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line: A Pilot Monocentric Open Randomized and Cross-over Study.
- ClinicalTrials.gov ID
- NCT00804453
- Acronym / sponsor ID
- 1455
- Conditions
- Chronic Kidney Failure
- Keywords
- Chronic Kidney Failure, Hemodialysis, Biocompatibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Lundia AB, Baxter Healthcare Corporation
- Study start
- Nov 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 8 Dec 2008 (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 primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.
Detailed description
Interactions between blood components (cells and proteins) and the extracorporeal circuit induce the activation of several biological systems such as platelets, complement and coagulation cascades. The coagulation system generates a key enzyme, factor IIa or thrombin, responsible for blood clotting in the dialysis circuit Because clotting in the circuit may reduce the dialysis efficiency, the anticoagulation of the extracorporeal circuit is needed .
For several years, most of the researches were mainly focused on the improvement of the biocompatibility of dialysis membranes .
The contribution of the various components of the dialysis circuit on the coagulation activation has not been clearly established.
A circuit integrating a cartridge blood set is commercialised for several years. The design of this cartridge blood set reduces the surface in contact with blood and minimizes the blood air interface which are well known sources of coagulation activation.
The aim of this study is to collect data to evaluate the biocompatibility of two types of blood circuit (cartridge blood set vs standard blood line).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Standard blood lineStandard blood line |
| 2 | Experimental | Device: Cartridge blood setCartridge blood line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients suffering from chronic renal failure,
- Patients treated in HD performed with or without heparin injection in the extra corporeal circuit (ECC) irrespective the type of heparin (UFH and LMWH),
- Patients treated three times a week for a minimum of three (3) months,
- Patients 18 years or older,
- Patients with a well-functioning vascular access as judged by the investigator,
Key exclusion criteria (9 listed)
- Patients with known allergy to heparin,
- Patients with acute inflammatory event that may affect, as judged by the investigator, the results of the study or the safety of the patients,
- Active malignant disease,
- Pregnant women, nursing mothers and women planning a pregnancy during the course of the study,
- Patients under guardianship,
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 |
|---|---|---|
| Cartridge blood setOnce a week | Device | 2 |
| Standard blood lineOnce a week | Device | 1 |
Primary outcome
The biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation.
Time frame: During dialysis treatment
1 secondary outcome
The quality of the restitution of both the filter and the circuit, at the end of each treatment, will be evaluated via visual scales.
Time frame: End of dialysis treatment
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 Mar 2025.
- Background: PubMed 16433843Lucchi L, Ligabue G, Marietta M, Delnevo A, Malagoli M, Perrone S, Stipo L, Grandi F, Albertazzi A. Activation of coagulation during hemodialysis: effect of blood lines alone and whole extracorporeal circuit. Artif Organs. 2006 Feb;30(2):106-10. doi: 10.1111/j.1525-1594.2006.00188.x.
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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.
Walid Arkouche, Dr principal investigator
AURAL dialysis centre Lyon France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cartridge blood set and Standard blood line in people with Chronic Kidney Failure, run by Vantive Health LLC at 1 site 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 7 inclusion and 9 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 Mar 2025. 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 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 biocompatibility will be followed, during dialysis treatment, by measuring TAT complex generation. (time frame: During dialysis treatment). 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 NCT00804453, which also lists 1 linked publication.
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 Mar 2025.