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The Use of Low Molecular Weight Heparin in Hemodiafiltration

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
At start of the session, at the inlet line
5 minutes after the start of the session, at the inlet line
At the start of the session, at the outlet line
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring stage V, treated, hemodiafiltration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Anti-Xa activity at the end of the session

Secondary Outcome Measures

Anti-Xa activity during the session
ETP during the session
Reduction ratio of urea
Reduction ratio of beta2microglobulin
Visual inspection of membrane and circuit
pressure measurements along the circuit
inlet blood line, prefilter, transmembrane, outlet blood line

Full Information

First Posted
September 18, 2008
Last Updated
May 13, 2015
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00756145
Brief Title
The Use of Low Molecular Weight Heparin in Hemodiafiltration
Official Title
The Use of Low Molecular Weight Heparin in Hemodiafiltration
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
stage V, treated, hemodiafiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Injection of LMWH at the start of the hemodiafiltration session, at the inlet bloodline
Arm Title
2
Arm Type
Experimental
Arm Description
Injection of LMWH 5 minutes after the start of the hemodiafiltration session, at the inlet bloodline
Arm Title
3
Arm Type
Experimental
Arm Description
Injection of LMWH at the start of the hemodiafiltration session, at the outline bloodline
Intervention Type
Procedure
Intervention Name(s)
At start of the session, at the inlet line
Intervention Description
Injection of LMWH at the inlet line, at the start of the hemodiafiltration session
Intervention Type
Procedure
Intervention Name(s)
5 minutes after the start of the session, at the inlet line
Intervention Description
Injection of LMWH at the inlet line, 5 minutes after the start of the hemodiafiltration session
Intervention Type
Procedure
Intervention Name(s)
At the start of the session, at the outlet line
Intervention Description
Injection of LMWH at the outlet line, at the start of the hemodiafiltration session
Primary Outcome Measure Information:
Title
Anti-Xa activity at the end of the session
Time Frame
240 min after start
Secondary Outcome Measure Information:
Title
Anti-Xa activity during the session
Time Frame
at start, 30 min, 120 min and 180 min
Title
ETP during the session
Time Frame
at start, 30 min, 120 min, 180 min and 240 min
Title
Reduction ratio of urea
Time Frame
after 10min, 180min and 240min
Title
Reduction ratio of beta2microglobulin
Time Frame
after 10min, 180min and 240min
Title
Visual inspection of membrane and circuit
Time Frame
After the hemodiafiltration session
Title
pressure measurements along the circuit
Description
inlet blood line, prefilter, transmembrane, outlet blood line
Time Frame
during the session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemieke Dhondt, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
26076014
Citation
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.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

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The Use of Low Molecular Weight Heparin in Hemodiafiltration

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