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Sponsors and Collaborators: |
Ullevaal University Hospital Rikshospitalet University Hospital |
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Information provided by: | Ullevaal University Hospital |
ClinicalTrials.gov Identifier: | NCT00594607 |
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 |
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Extracorporeal Clotting During Hemodialysis |
Device: AN69ST dialysis membrane Device: Fx8 (Fresenius) |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Crossover Assignment, Efficacy Study |
Official Title: | A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis |
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 |
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1: AN69ST: Active Comparator
Hemodialysis sessions with use of the dialysis filter AN69ST.
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Device: AN69ST dialysis membrane
AN69ST is the filter that the blood goes through during hemodialysis
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2:Fx8: Active Comparator
Hemodialysis sessions with use of the dialysis filter Fx8
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Device: Fx8 (Fresenius)
Polysulphone dialysis membrane
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
Department of Nephrology, Ullevål University Hospital | |
Oslo, Norway, 0407 |
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: | Ullevaal University Hospital ( Solbjørg Sagedal, MD, PhD ) |
Study ID Numbers: | S-04147, NSD-data services 11056 |
Study First Received: | January 3, 2008 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00594607 |
Health Authority: | Norway: Department of Health |
clotting hemodialysis anticoagulation bleeding risk |
Hemorrhage |