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The Use of Low Molecular Weight Heparin in Hemodiafiltration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00756145
First Posted: September 19, 2008
Last Update Posted: May 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
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.

Condition Intervention Phase
Chronic Kidney Disease Procedure: At start of the session, at the inlet line Procedure: 5 minutes after the start of the session, at the inlet line Procedure: At the start of the session, at the outlet line Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Low Molecular Weight Heparin in Hemodiafiltration

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Anti-Xa activity at the end of the session [ Time Frame: 240 min after start ]

Secondary Outcome Measures:
  • 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 ]
    inlet blood line, prefilter, transmembrane, outlet blood line


Enrollment: 15
Study Start Date: September 2008
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Injection of LMWH at the inlet line, at the start of the hemodiafiltration session
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
Injection of LMWH at the inlet line, 5 minutes after the start of the hemodiafiltration session
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
Injection of LMWH at the outlet line, at the start of the hemodiafiltration session

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756145


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Annemieke Dhondt, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00756145     History of Changes
Other Study ID Numbers: 2008/421
First Submitted: September 18, 2008
First Posted: September 19, 2008
Last Update Posted: May 14, 2015
Last Verified: May 2015

Keywords provided by University Hospital, Ghent:
stage V
treated
hemodiafiltration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action