Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis

NCT ID: NCT00594607

Last Updated: 2011-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2008-05-31

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.

Conditions

Extracorporeal Clotting During Hemodialysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1: AN69ST

Hemodialysis sessions with use of the dialysis filter AN69ST.

Group Type: ACTIVE_COMPARATOR

AN69ST dialysis membrane

Intervention Type: DEVICE

AN69ST is the filter that the blood goes through during hemodialysis

2:Fx8

Hemodialysis sessions with use of the dialysis filter Fx8

Group Type: ACTIVE_COMPARATOR

Fx8 (Fresenius)

Intervention Type: DEVICE

Polysulphone dialysis membrane

Interventions

AN69ST dialysis membrane

AN69ST is the filter that the blood goes through during hemodialysis

Intervention Type: DEVICE

Fx8 (Fresenius)

Polysulphone dialysis membrane

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rikshospitalet University Hospital

OTHER

Sponsor Role: collaborator

Ullevaal University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ullevaal University Hospital

Principal Investigators

Solbjørg Sagedal, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Ullevål University hospital, 0407 Oslo

Anders Hartmann, PhD, MD

Role: STUDY_DIRECTOR

Department of Internal medicine, Rikshospitalet University Hospital, 0027 Oslo

Solbjørg Sagedal, PhD, MD

Role: STUDY_CHAIR

department of Nephrology, Ullevål University Hospital, Oslo

Locations

Department of Nephrology, Ullevål University Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

NSD-data services 11056

Identifier Type: -

Identifier Source: secondary_id

S-04147

Identifier Type: -

Identifier Source: org_study_id