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The Use of Low Molecular Weight Heparin in Hemodiafiltration

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00756145
First received: September 18, 2008
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Low Molecular Weight Heparin in Hemodiafiltration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Clearance of uremic toxins, clearance of LMWH, transmembrane pressure, prefilter pressure, pressure in efferent and afferent bloodline, clotting parameters [ Time Frame: During the hemodiafiltration session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual inspection of membrane and circuit [ Time Frame: After the hemodiafiltration session ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (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
Active Comparator: 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
Active Comparator: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 heparin besides the heparin used during dialysis
  • active bleeding
  • heparin associated allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756145

Contacts
Contact: Annemieke Dhondt, MD, PhD Annemie.dhondt@ugent.be

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

Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00756145     History of Changes
Other Study ID Numbers: 2008/421
Study First Received: September 18, 2008
Last Updated: February 1, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013