The Use of Low Molecular Weight Heparin in Hemodiafiltration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00756145
First received: September 18, 2008
Last updated: May 13, 2015
Last verified: May 2015
  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:
  • Anti-Xa activity at the end of the session [ Time Frame: 240 min after start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-Xa activity during the session [ Time Frame: at start, 30 min, 120 min and 180 min ] [ Designated as safety issue: No ]
  • ETP during the session [ Time Frame: at start, 30 min, 120 min, 180 min and 240 min ] [ Designated as safety issue: No ]
  • Reduction ratio of urea [ Time Frame: after 10min, 180min and 240min ] [ Designated as safety issue: No ]
  • Reduction ratio of beta2microglobulin [ Time Frame: after 10min, 180min and 240min ] [ Designated as safety issue: No ]
  • Visual inspection of membrane and circuit [ Time Frame: After the hemodiafiltration session ] [ Designated as safety issue: No ]
  • pressure measurements along the circuit [ Time Frame: during the session ] [ Designated as safety issue: No ]
    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

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 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
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

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:
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: May 13, 2015
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 May 21, 2015