Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00594607|
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : July 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Extracorporeal Clotting During Hemodialysis||Device: AN69ST dialysis membrane Device: Fx8 (Fresenius)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
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
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|