Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis

Ullevaal University Hospital

Status: Completed

Conditions: Extracorporeal Clotting During Hemodialysis

Treatments: Device: AN69ST dialysis membrane; Device: Fx8 (Fresenius)

Study type: Interventional

Funder types: Other

Identifiers

NCT00594607

S-04147

NSD-data services 11056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

1: AN69ST

Active Comparator group

Description:

Hemodialysis sessions with use of the dialysis filter AN69ST.

Treatment:

Device: AN69ST dialysis membrane

2:Fx8

Active Comparator group

Description:

Hemodialysis sessions with use of the dialysis filter Fx8

Treatment:

Device: Fx8 (Fresenius)