Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis

This study has been completed.
Sponsor:
Collaborator:
Rikshospitalet University Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00594607
First received: January 3, 2008
Last updated: July 3, 2011
Last verified: May 2008
  Purpose

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.


Condition Intervention
Extracorporeal Clotting During Hemodialysis
Device: AN69ST dialysis membrane
Device: Fx8 (Fresenius)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Clinical clotting in the air trap [ Time Frame: 14 days (6 consecutive HD sessions) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intravascular coagulation and platelet activation [ Time Frame: 14 days (6 HD sessions) ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: September 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594607

Locations
Norway
Department of Nephrology, Ullevål University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
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
  More Information

No publications provided

Responsible Party: Solbjørg Sagedal, MD, PhD, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00594607     History of Changes
Other Study ID Numbers: S-04147, NSD-data services 11056
Study First Received: January 3, 2008
Last Updated: July 3, 2011
Health Authority: Norway: Department of Health

Keywords provided by Oslo University Hospital:
clotting
hemodialysis
anticoagulation
bleeding risk

ClinicalTrials.gov processed this record on April 17, 2014