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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

Brief Summary:
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 or disease Intervention/treatment Phase
Extracorporeal Clotting During Hemodialysis Device: AN69ST dialysis membrane Device: Fx8 (Fresenius) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis
Study Start Date : September 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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




Primary Outcome Measures :
  1. Clinical clotting in the air trap [ Time Frame: 14 days (6 consecutive HD sessions) ]

Secondary Outcome Measures :
  1. Intravascular coagulation and platelet activation [ Time Frame: 14 days (6 HD sessions) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: May 2008

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