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The Use of Low Molecular Weight Heparin in Hemodiafiltration

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Renal Insufficiency
Urologic Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014