NCT00594607

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ullevaal University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	AN69ST dialysis membrane	AN69ST is the filter that the blood goes through during hemodialysis
DEVICE	Fx8 (Fresenius)	Polysulphone dialysis membrane

Timeline

• Start date: 2004-09-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-01-15
• Last updated: 2011-07-06

Locations

1 site across 1 country: Norway