Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis

July 3, 2011 updated by: Ullevaal University Hospital

A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis

The purpose of this study is to investigate whether the dialysis filter AN69ST (Nephral 400 ST Dialysis Membrane) induces less clotting during hemodialysis than a conventional polysulphone filter. Our hypothesis is that the two filters induce the same degree of clotting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Six consecutive hemodialysis (HD) sessions are evaluated per patient, altogether 10 - 12 stable HD patients (or at least 48 HD sessions altogether). During these six sessions, AN69ST and Fx8 are used on alternate days. Dalteparin is given intravenously as a single bolus dose at start of HD (50% of the conventional dose). Clinical clotting is evaluated visually each hour of HD after blood draining of the venous air trap: 1=no clot, 2=a fibrinous ring, 3=a clot <1 cm, 4=a clot >1 cm and 5=coagulated system (stop in HD).

Blood specimens are taken at start and after each hour of HD. Markers of coagulation (prothrombin 1+2) and of platelets (beta-thromboglobulin) are evaluated as well as anti FXa-activity.

The two filters are going to be compared statistically with respect to the degree of clinical clotting and of intravascular coagulation and platelets activation.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • Norway
      • Oslo, Norway, 0407
        • Department of Nephrology, Ullevål University Hospital

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:

  • patient aged 18 years or more having been in chronic HD for at least 1 month
  • dialysis time at least 4 hours 3 times per week
  • blood flow at least 200 ml/min
  • Fragmin dose unchanged the last week before study start
  • Fragmin given intravenously as one single dose at HD start
  • Haemoglobin >= 11.0 g/dL and stable +/- 20% the last week before study start
  • erythropoietin and iron dose unchanged the last week before study start
  • written and orally informed consent given by the patient

Exclusion Criteria:

  • treatment with acetylsalicylic acid (ASA)
  • use of Warfarin or another oral anticoagulant
  • clinical signs of infection
  • disseminated malignant disease

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1: AN69ST
Hemodialysis sessions with use of the dialysis filter AN69ST.
Device: AN69ST dialysis membrane
AN69ST is the filter that the blood goes through during hemodialysis
Active Comparator: 2:Fx8
Hemodialysis sessions with use of the dialysis filter Fx8
Device: Fx8 (Fresenius)
Polysulphone dialysis membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical clotting in the air trap
Time Frame: 14 days (6 consecutive HD sessions)
14 days (6 consecutive HD sessions)

Secondary Outcome Measures

Outcome Measure
Time Frame
Intravascular coagulation and platelet activation
Time Frame: 14 days (6 HD sessions)
14 days (6 HD sessions)

Collaborators and Investigators

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

Sponsor

Ullevaal University Hospital

Collaborators

Rikshospitalet University Hospital

Investigators

  • Principal Investigator: Solbjørg Sagedal, PhD, MD, Department of Nephrology, Ullevål University hospital, 0407 Oslo
  • Study Director: Anders Hartmann, PhD, MD, Department of Internal medicine, Rikshospitalet University Hospital, 0027 Oslo
  • Study Chair: Solbjørg Sagedal, PhD, MD, department of Nephrology, Ullevål University Hospital, Oslo

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, 2004

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S-04147
  • NSD-data services 11056

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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