Chronic Kidney DiseasePhase 4NCT00756145
The Use of Low Molecular Weight Heparin in Hemodiafiltration
A Phase 4 study testing At start of the session, at the inlet line, 5 minutes after the start of the session, at the inlet line and At the start of the session, at the outlet line in people with Chronic Kidney Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- At start of the session, at the inlet line, 5 minutes after the start of the session, at the inlet line and At the start of the session, at the outlet line
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2008to May 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
- chronic kidney disease stade V treated with hemodiafiltration
- age >18 year
- Hematocrit > 30%
Who cannot join
- treatment with vitamin K antagonists
- treatment with other anti-coagulants or heparin besides the heparin used during dialysis
- active bleeding, infection or malignancy
- heparin associated allergy
- hepatic failure
- trombocytopenia < 120.000/µl
Trial locations and contacts
1 site in 1 country.
About this study
Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each patient.
- Conditions
- Chronic Kidney Disease
- Being tested
- At start of the session, at the inlet line, 5 minutes after the start of the session, at the inlet line, At the start of the session, at the outlet line
- Keywords
- stage V, treated, hemodiafiltration
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At start of the session, at the inlet lineProcedure or surgery
Injection of LMWH at the inlet line, at the start of the hemodiafiltration session
5 minutes after the start of the session, at the inlet lineProcedure or surgery
Injection of LMWH at the inlet line, 5 minutes after the start of the hemodiafiltration session
At the start of the session, at the outlet lineProcedure or surgery
Injection of LMWH at the outlet line, at the start of the hemodiafiltration session
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Injection of LMWH at the start of the hemodiafiltration session, at the inlet bloodline Receives: Procedure: At start of the session, at the inlet line |
| 2 | Experimental | Injection of LMWH 5 minutes after the start of the hemodiafiltration session, at the inlet bloodline Receives: Procedure: 5 minutes after the start of the session, at the inlet line |
| 3 | Experimental | Injection of LMWH at the start of the hemodiafiltration session, at the outline bloodline Receives: Procedure: At the start of the session, at the outlet line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Xa activity at the end of the session
Measured: 240 min after start
Secondary outcomes (6)
Anti-Xa activity during the session
Measured: at start, 30 min, 120 min and 180 min
ETP during the session
Measured: at start, 30 min, 120 min, 180 min and 240 min
Reduction ratio of urea
Measured: after 10min, 180min and 240min
Reduction ratio of beta2microglobulin
Measured: after 10min, 180min and 240min
Visual inspection of membrane and circuit
Measured: After the hemodiafiltration session
pressure measurements along the circuit
inlet blood line, prefilter, transmembrane, outlet blood line
Measured: during the session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2015
- Study completionMay 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 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemieke Dhondt, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756145
- Sponsor's protocol ID
- 2008/421
- Status last verified
- May 2015
- First submitted
- 18 Sep 2008
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
PubMed 38189593Dhondt A, Pauwels R, Devreese K, Eloot S, Glorieux G, Vanholder R. Where and When To Inject Low Molecular Weight Heparin in Hemodiafiltration? A Cross Over Randomised Trial. PLoS One. 2015 Jun 15;10(6):e0128634. doi: 10.1371/journal.pone.0128634. eCollection 2015.
PubMed 26076014
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Low Molecular Weight Heparin in Hemodiafiltration
- ClinicalTrials.gov ID
- NCT00756145
- Acronym / sponsor ID
- 2008/421
- Conditions
- Chronic Kidney Disease
- Keywords
- stage V, treated, hemodiafiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Sep 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.
Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: At start of the session, at the inlet lineInjection of LMWH at the start of the hemodiafiltration session, at the inlet bloodline |
| 2 | Experimental | Procedure: 5 minutes after the start of the session, at the inlet lineInjection of LMWH 5 minutes after the start of the hemodiafiltration session, at the inlet bloodline |
| 3 | Experimental | Procedure: At the start of the session, at the outlet lineInjection of LMWH at the start of the hemodiafiltration session, at the outline bloodline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic kidney disease stade V treated with hemodiafiltration
- age >18 year
- Hematocrit > 30%
Key exclusion criteria (6 listed)
- treatment with vitamin K antagonists
- treatment with other anti-coagulants or heparin besides the heparin used during dialysis
- active bleeding, infection or malignancy
- heparin associated allergy
- hepatic failure
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 |
|---|---|---|
| At start of the session, at the inlet lineInjection of LMWH at the inlet line, at the start of the hemodiafiltration session | Procedure or surgery | 1 |
| 5 minutes after the start of the session, at the inlet lineInjection of LMWH at the inlet line, 5 minutes after the start of the hemodiafiltration session | Procedure or surgery | 2 |
| At the start of the session, at the outlet lineInjection of LMWH at the outlet line, at the start of the hemodiafiltration session | Procedure or surgery | 3 |
Primary outcome
Anti-Xa activity at the end of the session
Time frame: 240 min after start
6 secondary outcomes
Anti-Xa activity during the session
Time frame: at start, 30 min, 120 min and 180 min
ETP during the session
Time frame: at start, 30 min, 120 min, 180 min and 240 min
Reduction ratio of urea
Time frame: after 10min, 180min and 240min
Reduction ratio of beta2microglobulin
Time frame: after 10min, 180min and 240min
Visual inspection of membrane and circuit
Time frame: After the hemodiafiltration session
pressure measurements along the circuit
Time frame: during the session
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 14 May 2015.
- Derived from this study: PubMed 38189593Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
- Derived from this study: PubMed 26076014Dhondt A, Pauwels R, Devreese K, Eloot S, Glorieux G, Vanholder R. Where and When To Inject Low Molecular Weight Heparin in Hemodiafiltration? A Cross Over Randomised Trial. PLoS One. 2015 Jun 15;10(6):e0128634. doi: 10.1371/journal.pone.0128634. eCollection 2015.
- Website of the University Hospital GhentLink provided by the sponsor.
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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.
Annemieke Dhondt, MD, PhD principal investigator
University Hospital, Ghent
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 At start of the session, at the inlet line, 5 minutes after the start of the session, at the inlet line and At the start of the session, at the outlet line in people with Chronic Kidney Disease, run by University Hospital, Ghent at 1 site in Belgium.
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 3 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 14 May 2015. 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 Belgium. 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?
Anti-Xa activity at the end of the session (time frame: 240 min after start). 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 NCT00756145, 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 14 May 2015.