Extracorporeal Clotting During HemodialysisNCT00594607
Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis
A study testing AN69ST dialysis membrane and Fx8 (Fresenius) in people with Extracorporeal Clotting During Hemodialysis, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to investigate whether the dialysis filter AN69ST (Nephral 400 ST Dialysis Membrane) induces less clotting during hemodialysis than a conventional polysulphone filter. Our hypothesis is that the two filters induce the same degree of clotting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Clotting During Hemodialysis
- What is being tested?
- AN69ST dialysis membrane and Fx8 (Fresenius)
- 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 2004to May 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
- patient aged 18 years or more having been in chronic HD for at least 1 month
- dialysis time at least 4 hours 3 times per week
- blood flow at least 200 ml/min
- Fragmin dose unchanged the last week before study start
- Fragmin given intravenously as one single dose at HD start
- Haemoglobin >= 11.0 g/dL and stable +/- 20% the last week before study start
- erythropoietin and iron dose unchanged the last week before study start
- written and orally informed consent given by the patient
Who cannot join
- treatment with acetylsalicylic acid (ASA)
- use of Warfarin or another oral anticoagulant
- clinical signs of infection
- disseminated malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis
The purpose of this study is to investigate whether the dialysis filter AN69ST (Nephral 400 ST Dialysis Membrane) induces less clotting during hemodialysis than a conventional polysulphone filter. Our hypothesis is that the two filters induce the same degree of clotting.
Read the detailed description
Six consecutive hemodialysis (HD) sessions are evaluated per patient, altogether 10 - 12 stable HD patients (or at least 48 HD sessions altogether). During these six sessions, AN69ST and Fx8 are used on alternate days. Dalteparin is given intravenously as a single bolus dose at start of HD (50% of the conventional dose). Clinical clotting is evaluated visually each hour of HD after blood draining of the venous air trap: 1=no clot, 2=a fibrinous ring, 3=a clot <1 cm, 4=a clot >1 cm and 5=coagulated system (stop in HD).
Blood specimens are taken at start and after each hour of HD. Markers of coagulation (prothrombin 1+2) and of platelets (beta-thromboglobulin) are evaluated as well as anti FXa-activity.
The two filters are going to be compared statistically with respect to the degree of clinical clotting and of intravascular coagulation and platelets activation.
- Being tested
- AN69ST dialysis membrane, Fx8 (Fresenius)
- Keywords
- clotting, hemodialysis, anticoagulation, bleeding risk
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN69ST dialysis membraneDevice
AN69ST is the filter that the blood goes through during hemodialysis
Fx8 (Fresenius)Device
Polysulphone dialysis membrane
| Study group | Role | What they receive |
|---|---|---|
| 1: AN69ST | Active comparator | Hemodialysis sessions with use of the dialysis filter AN69ST. Receives: Device: AN69ST dialysis membrane |
| 2:Fx8 | Active comparator | Hemodialysis sessions with use of the dialysis filter Fx8 Receives: Device: Fx8 (Fresenius) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical clotting in the air trap
Measured: 14 days (6 consecutive HD sessions)
Secondary outcomes (1)
Intravascular coagulation and platelet activation
Measured: 14 days (6 HD sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startSep 2004
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Clotting During HemodialysisStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rikshospitalet University Hospital
- Investigators
- Solbjørg Sagedal, PhD, MD, Principal investigator, Department of Nephrology, Ullevål University hospital, 0407 OsloAnders Hartmann, PhD, MD, Study director, Department of Internal medicine, Rikshospitalet University Hospital, 0027 OsloSolbjørg Sagedal, PhD, MD, Study chair, department of Nephrology, Ullevål University Hospital, Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594607
- Sponsor's protocol ID
- S-04147
- Other IDs
- NSD-data services 11056
- Status last verified
- May 2008
- First submitted
- 3 Jan 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis
- ClinicalTrials.gov ID
- NCT00594607
- Acronym / sponsor ID
- S-04147
- Keywords
- clotting, hemodialysis, anticoagulation, bleeding risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Rikshospitalet University Hospital
- Study start
- Sep 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 Jan 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 purpose of this study is to investigate whether the dialysis filter AN69ST (Nephral 400 ST Dialysis Membrane) induces less clotting during hemodialysis than a conventional polysulphone filter. Our hypothesis is that the two filters induce the same degree of clotting.
Detailed description
Six consecutive hemodialysis (HD) sessions are evaluated per patient, altogether 10 - 12 stable HD patients (or at least 48 HD sessions altogether). During these six sessions, AN69ST and Fx8 are used on alternate days. Dalteparin is given intravenously as a single bolus dose at start of HD (50% of the conventional dose). Clinical clotting is evaluated visually each hour of HD after blood draining of the venous air trap: 1=no clot, 2=a fibrinous ring, 3=a clot <1 cm, 4=a clot >1 cm and 5=coagulated system (stop in HD).
Blood specimens are taken at start and after each hour of HD. Markers of coagulation (prothrombin 1+2) and of platelets (beta-thromboglobulin) are evaluated as well as anti FXa-activity.
The two filters are going to be compared statistically with respect to the degree of clinical clotting and of intravascular coagulation and platelets activation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: AN69ST | Active comparator | Device: AN69ST dialysis membraneHemodialysis sessions with use of the dialysis filter AN69ST. |
| 2:Fx8 | Active comparator | Device: Fx8 (Fresenius)Hemodialysis sessions with use of the dialysis filter Fx8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patient aged 18 years or more having been in chronic HD for at least 1 month
- dialysis time at least 4 hours 3 times per week
- blood flow at least 200 ml/min
- Fragmin dose unchanged the last week before study start
- Fragmin given intravenously as one single dose at HD start
Key exclusion criteria (4 listed)
- treatment with acetylsalicylic acid (ASA)
- use of Warfarin or another oral anticoagulant
- clinical signs of infection
- disseminated malignant disease
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 dialysis membraneAN69ST is the filter that the blood goes through during hemodialysis | Device | 1: AN69ST |
| Fx8 (Fresenius)Polysulphone dialysis membrane | Device | 2:Fx8 |
Primary outcome
Clinical clotting in the air trap
Time frame: 14 days (6 consecutive HD sessions)
1 secondary outcome
Intravascular coagulation and platelet activation
Time frame: 14 days (6 HD 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 6 Jul 2011.
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, MD principal investigator
Department of Nephrology, Ullevål University hospital, 0407 Oslo
Anders Hartmann, PhD, MD study director
Department of Internal medicine, Rikshospitalet University Hospital, 0027 Oslo
Solbjørg Sagedal, PhD, MD study chair
department of Nephrology, Ullevål University Hospital, Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AN69ST dialysis membrane and Fx8 (Fresenius) in people with Extracorporeal Clotting During Hemodialysis, run by Ullevaal 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 8 inclusion and 4 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 6 Jul 2011. 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.
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?
Clinical clotting in the air trap (time frame: 14 days (6 consecutive HD 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 6 Jul 2011.