Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00594607

Enrollment

Registered

2008-01-15

Start date

2004-09-30

Completion date

2008-05-31

Last updated

2011-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Clotting During Hemodialysis

Keywords

clotting, hemodialysis, anticoagulation, bleeding risk

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.

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.

Interventions

DEVICEAN69ST dialysis membrane

AN69ST is the filter that the blood goes through during hemodialysis

DEVICEFx8 (Fresenius)

Polysulphone dialysis membrane

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical clotting in the air trap	14 days (6 consecutive HD sessions)

Secondary

Measure	Time frame
Intravascular coagulation and platelet activation	14 days (6 HD sessions)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026