Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis - Full Text View

Sponsors and Collaborators:	Ullevaal University Hospital Rikshospitalet University Hospital
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00594607

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)

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

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

Further study details as provided by Ullevaal 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
1: AN69ST: Active Comparator Hemodialysis sessions with use of the dialysis filter AN69ST.	Device: AN69ST dialysis membrane AN69ST is the filter that the blood goes through during hemodialysis
2:Fx8: Active Comparator 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

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

Keywords provided by Ullevaal University Hospital:

clotting
hemodialysis
anticoagulation
bleeding risk

Study placed in the following topic categories:

Hemorrhage

ClinicalTrials.gov processed this record on January 16, 2009