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| ID | Type | Description | Link |
|---|---|---|---|
| NSD-data services 11056 |
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| Name | Class |
|---|---|
| Rikshospitalet University Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: AN69ST | Active Comparator | Hemodialysis sessions with use of the dialysis filter AN69ST. |
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| 2:Fx8 | Active Comparator | Hemodialysis sessions with use of the dialysis filter Fx8 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN69ST dialysis membrane | Device | AN69ST is the filter that the blood goes through during hemodialysis |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical clotting in the air trap | 14 days (6 consecutive HD sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| Intravascular coagulation and platelet activation | 14 days (6 HD sessions) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Solbjørg Sagedal, PhD, MD | Department of Nephrology, Ullevål University hospital, 0407 Oslo | Principal Investigator |
| Anders Hartmann, PhD, MD | Department of Internal medicine, Rikshospitalet University Hospital, 0027 Oslo | Study Director |
| Solbjørg Sagedal, PhD, MD | department of Nephrology, Ullevål University Hospital, Oslo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology, Ullevål University Hospital | Oslo | 0407 | Norway |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Fx8 (Fresenius) | Device | Polysulphone dialysis membrane |
|