Extracorporeal Clotting During Hemodialysis Clinical Trial
Official title:
A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention