Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis
|Extracorporeal Clotting During Hemodialysis||Device: AN69ST dialysis membrane Device: Fx8 (Fresenius)|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis|
- Clinical clotting in the air trap [ Time Frame: 14 days (6 consecutive HD sessions) ]
- Intravascular coagulation and platelet activation [ Time Frame: 14 days (6 HD sessions) ]
|Study Start Date:||September 2004|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1: AN69ST
Hemodialysis sessions with use of the dialysis filter AN69ST.
Device: AN69ST dialysis membrane
AN69ST is the filter that the blood goes through during hemodialysis
Active Comparator: 2:Fx8
Hemodialysis sessions with use of the dialysis filter Fx8
Device: Fx8 (Fresenius)
Polysulphone dialysis membrane
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594607
|Department of Nephrology, Ullevål University Hospital|
|Oslo, Norway, 0407|
|Principal Investigator:||Solbjørg Sagedal, PhD, MD||Department of Nephrology, Ullevål University hospital, 0407 Oslo|
|Study Director:||Anders Hartmann, PhD, MD||Department of Internal medicine, Rikshospitalet University Hospital, 0027 Oslo|
|Study Chair:||Solbjørg Sagedal, PhD, MD||department of Nephrology, Ullevål University Hospital, Oslo|