Clinical trial NCT00594607: Effect of Nephral 400 ST Dialysis Membrane on Coagulation in Hemodialysis
Official title: A Comparing Study of Nephral 400 ST and Fx8 Dialysis Membranes on Coagulation During Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extracorporeal Clotting During Hemodialysis
Keywords: clotting
hemodialysis
anticoagulation
bleeding risk
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Rikshospitalet University Hospital
First posted: 2008-01-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* patient aged 18 years or more having been in chronic HD for at least 1 month
* dialysis time at least 4 hours 3 times per week
* blood flow at least 200 ml/min
* Fragmin dose unchanged the last week before study start
* Fragmin given intravenously as one single dose at HD start
* Haemoglobin \>= 11.0 g/dL and stable +/- 20% the last week before study start
* erythropoietin and iron dose unchanged the last week before study start
* written and orally informed consent given by the patient

Exclusion Criteria:

* treatment with acetylsalicylic acid (ASA)
* use of Warfarin or another oral anticoagulant
* clinical signs of infection
* disseminated malignant disease

Primary outcomes:
measure: Clinical clotting in the air trap
timeFrame: 14 days (6 consecutive HD sessions)
Secondary outcomes:
measure: Intravascular coagulation and platelet activation
timeFrame: 14 days (6 HD sessions)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Nephrology, Ullevål University Hospital
Study officials:
affiliation: Department of Nephrology, Ullevål University hospital, 0407 Oslo
name: Solbjørg Sagedal, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal medicine, Rikshospitalet University Hospital, 0027 Oslo
name: Anders Hartmann, PhD, MD
role: STUDY_DIRECTOR
affiliation: department of Nephrology, Ullevål University Hospital, Oslo
name: Solbjørg Sagedal, PhD, MD
role: STUDY_CHAIR
References: