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CompletedNCT00756145Updated May 14, 2015

The Use of Low Molecular Weight Heparin in Hemodiafiltration

A Phase 4 interventional study of At start of the session, at the inlet line and 5 minutes after the start of the session, at the inlet line in Chronic Kidney Disease, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-14.

Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • stage V
  • treated
  • hemodiafiltration
03

In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's enrollment of 15 is below the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 685 studies on the registry; 158 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Browse University Hospital, Ghent studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • chronic kidney disease stade V treated with hemodiafiltration
  • age >18 year
  • Hematocrit > 30%

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    1

    Injection of LMWH at the start of the hemodiafiltration session, at the inlet bloodline

    Procedure: At start of the session, at the inlet line

  • Experimental
    2

    Injection of LMWH 5 minutes after the start of the hemodiafiltration session, at the inlet bloodline

    Procedure: 5 minutes after the start of the session, at the inlet line

  • Experimental
    3

    Injection of LMWH at the start of the hemodiafiltration session, at the outline bloodline

    Procedure: At the start of the session, at the outlet line

Interventions

  • ProcedureAt start of the session, at the inlet line

    Injection of LMWH at the inlet line, at the start of the hemodiafiltration session

  • Procedure5 minutes after the start of the session, at the inlet line

    Injection of LMWH at the inlet line, 5 minutes after the start of the hemodiafiltration session

  • ProcedureAt the start of the session, at the outlet line

    Injection of LMWH at the outlet line, at the start of the hemodiafiltration session

06

What researchers measure

Primary outcomes

  1. Anti-Xa activity at the end of the session

    Time frame: 240 min after start

Secondary outcomes

  1. Anti-Xa activity during the session

    Time frame: at start, 30 min, 120 min and 180 min

  2. ETP during the session

    Time frame: at start, 30 min, 120 min, 180 min and 240 min

  3. Reduction ratio of urea

    Time frame: after 10min, 180min and 240min

  4. Reduction ratio of beta2microglobulin

    Time frame: after 10min, 180min and 240min

  5. Visual inspection of membrane and circuit

    Time frame: After the hemodiafiltration session

  6. pressure measurements along the circuit

    inlet blood line, prefilter, transmembrane, outlet blood line

    Time frame: during the session

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

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 38189593 ↗
  • Dhondt 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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2008, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2008
First posted
Sep 19, 2008
Start
Sep 2008
Primary completionActual
May 2015
CompletionActual
May 2015
Last update
May 14, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00756145
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Sep 19, 2008
Start date
Sep 2008
Primary completion
May 2015
Completion
May 2015
Last update
May 14, 2015

Study contacts

Annemieke Dhondt, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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