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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014