The Use of Low Molecular Weight Heparin in Hemodiafiltration

May 13, 2015 updated by: University Hospital, Ghent
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-Xa activity at the end of the session
Time Frame: 240 min after start
240 min after start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Xa activity during the session
Time Frame: at start, 30 min, 120 min and 180 min
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
at start, 30 min, 120 min, 180 min and 240 min
Reduction ratio of urea
Time Frame: after 10min, 180min and 240min
after 10min, 180min and 240min
Reduction ratio of beta2microglobulin
Time Frame: after 10min, 180min and 240min
after 10min, 180min and 240min
Visual inspection of membrane and circuit
Time Frame: After the hemodiafiltration session
After the hemodiafiltration session
pressure measurements along the circuit
Time Frame: during the session
inlet blood line, prefilter, transmembrane, outlet blood line
during the session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (ESTIMATE)

September 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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