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Completed

NCT Number: NCT00594607

Effect of Nephral 400 ST Dialysis Membrane on Coagulation in 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.

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Key information

Conditions

Extracorporeal Clotting During Hemodialysis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nephrology, Ullevål University Hospital

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AN69ST dialysis membrane

Device

AN69ST is the filter that the blood goes through during hemodialysis

Fx8 (Fresenius)

Device

Polysulphone dialysis membrane

Primary outcomes

  1. Clinical clotting in the air trap

    Time frame: 14 days (6 consecutive HD sessions)

Secondary outcomes

  1. Intravascular coagulation and platelet activation

    Time frame: 14 days (6 HD sessions)

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • Rikshospitalet University Hospital

Registry information

Official study title

A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jan 15, 2008
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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