Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis

Extracorporeal Clotting During Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594607
• Other study ID #: S-04147
• Secondary ID: NSD-data service
• Status: Completed
• Phase: N/A
• First received: January 3, 2008
• Last updated: July 3, 2011
• Start date: September 2004
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Extracorporeal Clotting During Hemodialysis

Intervention

Device:
• AN69ST dialysis membrane
AN69ST is the filter that the blood goes through during hemodialysis
• Fx8 (Fresenius)
Polysulphone dialysis membrane

Locations

Country	Name	City	State
Norway	Department of Nephrology, Ullevål University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Rikshospitalet University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical clotting in the air trap		14 days (6 consecutive HD sessions)	No
Secondary	Intravascular coagulation and platelet activation		14 days (6 HD sessions)	No