Renal FailurePhase 4NCT01388270
Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis
A Phase 4 study testing a pre-heparin-coated hemodialysis filter; Hepran in people with Renal Failure, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether the heparin-coated dialysis filter is superior to a conventional filter during hemodialysis in twelve stable, chronic hemodialysis (HD) patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- a pre-heparin-coated hemodialysis filter; Hepran
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2011to Jan 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable HD patients of at least 18 years of age.
- HD treatment for at least one month.
- Dialysis time at least 4 hours three times per week.
- Stable Hemoglobin value of at least 11 g/dl during the last 4 weeks.
Who cannot join
- Use of warfarin and/or acetylsalicylic acid.
- Disseminated malignant disease.
- Clinical signs of infection.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of nephrology, Oslo University Hospital, Ullevål
Oslo, 0407
About this study
Official title: The Effect of a Heparin-coated Dialysis Filter (Evodial) on Clotting and Intravascular Coagulation During Hemodialysis (HD) When Compared to a Conventional Polyflux Filter (170H)
The purpose of this study is to determine whether the heparin-coated dialysis filter is superior to a conventional filter during hemodialysis in twelve stable, chronic hemodialysis (HD) patients.
The antithrombogenic properties of the heparin-coated dialysis filter and of the conventional filter will be compared by means of statistical tests.
Read the detailed description
In the present study twelve chronic hemodialysis (HD) patients will be included. Exclusion criteria are use of acetylsalicylic acid and/warfarin, clinical signs of infection and disseminated malignant disease. For each patient four HD sessions will be investigated; alternating with use of the pre-heparin-coated filter or the conventional filter. Dalteparin is reduced to 50% of the conventional dose and is given as one single bolus dose at start of HD.
The venous drip chamber will be visually inspected for evaluation of clot score during each HD session. The filter will be visually inspected for clot score at the end of each session.
Blood specimens will be drawn systematically during each HD session to evaluate platelet and coagulation activity as well as anti Factor Xa activity, haematology and urea/creatinine to evaluate dialysis effect.
The antithrombogenic properties of the pre-heparin-coated filter and the conventional filter will be compared by means of statistical tests. The hypothesis is that the pre-heparin-coated filter induces significantly less clot score in the extracorporeal system during hemodialysis and also significantly less intravascular activation of the coagulation system compared to the conventional filter.
- Conditions
- Renal Failure
- Being tested
- a pre-heparin-coated hemodialysis filter; Hepran
- Keywords
- Hemodialysis, Anticoagulation, Clotting, Coagulation, dalteparin, Clotting in the extracorporeal system during HD, Antithrombogenic property of Evodial HD filter, Anticoagulation during HD
- Medical subject headings
- Renal Insufficiency, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a pre-heparin-coated hemodialysis filter; HepranDevice
Also called HeprAN membrane, polyacrylonitrile, heparin-grafted membrane
Use of the pre-heparin-coated filter compared to the conventional filter in a cross over design
| Study group | Role | What they receive |
|---|---|---|
| Evodial | Active comparator | a pre-heparin-coated hemodialysis filter Receives: Device: a pre-heparin-coated hemodialysis filter; Hepran |
| 170 H | No intervention | Conventional filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of the intravascular coagulation system during hemodialysis with use of a pre-heparin-coated filter compared to a conventional filter
Blood specimens for analysis of prothrombin fragment 1+2 and beta-thromboglobulin will be drawn at start of hemodialysis and after three and four hours of all hemodialysis sessions.
Measured: Activation of the intravascular coagulation system is assessed during four dialysis sessions within a two weeks period for a single patient
Secondary outcomes (1)
A secondary outcome measure is degree of clot score in the extracorporeal system during hemodialysis with use of a pre-heparin-coated filter compared to the conventional filter.
Degree of clot score will be evaluated in the venous drip chamber as follows: 1=normal (no signs of clot). 2=fibrinous ring, 3=clot and 4=stop in dialysis due to high degree of clotting
Measured: The degree of clot score in the extracorporeal system is assessed during four hemodialysis sessions that for a single patient take place within a time frame of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Oslo University 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Solbjørg Sagedal, Oslo University Hospital
- Investigators
- Solbjørg Sagedal, PhD, Principal investigator, Oslo University hospital, Ullevål
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388270
- Sponsor's protocol ID
- 2010/3019-2
- Status last verified
- Feb 2016
- First submitted
- 29 Jun 2011
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Heparin-coated Dialysis Filter (Evodial) on Clotting and Intravascular Coagulation During Hemodialysis (HD) When Compared to a Conventional Polyflux Filter (170H)
- ClinicalTrials.gov ID
- NCT01388270
- Acronym / sponsor ID
- 2010/3019-2
- Conditions
- Renal Failure
- Keywords
- Hemodialysis, Anticoagulation, Clotting, Coagulation, dalteparin, Clotting in the extracorporeal system during HD, Antithrombogenic property of Evodial HD filter, Anticoagulation during HD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Jul 2011 (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 purpose of this study is to determine whether the heparin-coated dialysis filter is superior to a conventional filter during hemodialysis in twelve stable, chronic hemodialysis (HD) patients.
The antithrombogenic properties of the heparin-coated dialysis filter and of the conventional filter will be compared by means of statistical tests.
Detailed description
In the present study twelve chronic hemodialysis (HD) patients will be included. Exclusion criteria are use of acetylsalicylic acid and/warfarin, clinical signs of infection and disseminated malignant disease. For each patient four HD sessions will be investigated; alternating with use of the pre-heparin-coated filter or the conventional filter. Dalteparin is reduced to 50% of the conventional dose and is given as one single bolus dose at start of HD.
The venous drip chamber will be visually inspected for evaluation of clot score during each HD session. The filter will be visually inspected for clot score at the end of each session.
Blood specimens will be drawn systematically during each HD session to evaluate platelet and coagulation activity as well as anti Factor Xa activity, haematology and urea/creatinine to evaluate dialysis effect.
The antithrombogenic properties of the pre-heparin-coated filter and the conventional filter will be compared by means of statistical tests. The hypothesis is that the pre-heparin-coated filter induces significantly less clot score in the extracorporeal system during hemodialysis and also significantly less intravascular activation of the coagulation system compared to the conventional filter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evodial | Active comparator | Device: a pre-heparin-coated hemodialysis filter; Heprana pre-heparin-coated hemodialysis filter |
| 170 H | No intervention | –Conventional filter |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable HD patients of at least 18 years of age.
- HD treatment for at least one month.
- Dialysis time at least 4 hours three times per week.
- Stable Hemoglobin value of at least 11 g/dl during the last 4 weeks.
Key exclusion criteria (3 listed)
- Use of warfarin and/or acetylsalicylic acid.
- Disseminated malignant disease.
- Clinical signs of infection.
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 |
|---|---|---|
| a pre-heparin-coated hemodialysis filter; HepranAlso: HeprAN membrane, polyacrylonitrile, heparin-grafted membraneUse of the pre-heparin-coated filter compared to the conventional filter in a cross over design | Device | Evodial |
Primary outcome
Activation of the intravascular coagulation system during hemodialysis with use of a pre-heparin-coated filter compared to a conventional filter
Time frame: Activation of the intravascular coagulation system is assessed during four dialysis sessions within a two weeks period for a single patient
Blood specimens for analysis of prothrombin fragment 1+2 and beta-thromboglobulin will be drawn at start of hemodialysis and after three and four hours of all hemodialysis sessions.
1 secondary outcome
A secondary outcome measure is degree of clot score in the extracorporeal system during hemodialysis with use of a pre-heparin-coated filter compared to the conventional filter.
Time frame: The degree of clot score in the extracorporeal system is assessed during four hemodialysis sessions that for a single patient take place within a time frame of two weeks
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 4 Feb 2016.
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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.
Solbjørg Sagedal, PhD principal investigator
Oslo University hospital, Ullevål
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 a pre-heparin-coated hemodialysis filter; Hepran in people with Renal Failure, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 3 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 4 Feb 2016. 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 Norway. 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?
Activation of the intravascular coagulation system during hemodialysis with use of a pre-heparin-coated filter compared to a conventional filter (time frame: Activation of the intravascular coagulation system is assessed during four dialysis sessions within a two weeks period for a single patient). 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 4 Feb 2016.