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Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis

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ClinicalTrials.gov Identifier: NCT00594607
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : July 6, 2011
Sponsor:
Collaborator:
Rikshospitalet University Hospital
Information provided by:
Oslo University Hospital

January 3, 2008
January 15, 2008
July 6, 2011
September 2004
May 2008   (Final data collection date for primary outcome measure)
Clinical clotting in the air trap [ Time Frame: 14 days (6 consecutive HD sessions) ]
Same as current
Complete list of historical versions of study NCT00594607 on ClinicalTrials.gov Archive Site
Intravascular coagulation and platelet activation [ Time Frame: 14 days (6 HD sessions) ]
Same as current
Not Provided
Not Provided
 
Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis
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.

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.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Extracorporeal Clotting During Hemodialysis
  • Device: AN69ST dialysis membrane
    AN69ST is the filter that the blood goes through during hemodialysis
  • Device: Fx8 (Fresenius)
    Polysulphone dialysis membrane
  • Active Comparator: 1: AN69ST
    Hemodialysis sessions with use of the dialysis filter AN69ST.
    Intervention: Device: AN69ST dialysis membrane
  • Active Comparator: 2:Fx8
    Hemodialysis sessions with use of the dialysis filter Fx8
    Intervention: Device: Fx8 (Fresenius)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Same as current
May 2008
May 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT00594607
S-04147
NSD-data services 11056
No
Not Provided
Not Provided
Solbjørg Sagedal, MD, PhD, Ullevaal University Hospital
Ullevaal University Hospital
Rikshospitalet University Hospital
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
Oslo University Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP