Clinical trial NCT01388270: Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis
Official title: The Effect of a Heparin-coated Dialysis Filter (Evodial) on Clotting and Intravascular Coagulation During Hemodialysis (HD) When Compared to a Conventional Polyflux Filter (170H)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Failure
Keywords: Hemodialysis
Anticoagulation
Clotting
Coagulation
dalteparin
Clotting in the extracorporeal system during HD
Antithrombogenic property of Evodial HD filter
Anticoagulation during HD
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the heparin-coated dialysis filter is superior to a conventional filter during hemodialysis in twelve stable, chronic hemodialysis (HD) patients.

The antithrombogenic properties of the heparin-coated dialysis filter and of the conventional filter will be compared by means of statistical tests.

Detailed description: In the present study twelve chronic hemodialysis (HD) patients will be included. Exclusion criteria are use of acetylsalicylic acid and/warfarin, clinical signs of infection and disseminated malignant disease. For each patient four HD sessions will be investigated; alternating with use of the pre-heparin-coated filter or the conventional filter. Dalteparin is reduced to 50% of the conventional dose and is given as one single bolus dose at start of HD.

The venous drip chamber will be visually inspected for evaluation of clot score during each HD session. The filter will be visually inspected for clot score at the end of each session.

Blood specimens will be drawn systematically during each HD session to evaluate platelet and coagulation activity as well as anti Factor Xa activity, haematology and urea/creatinine to evaluate dialysis effect.

The antithrombogenic properties of the pre-heparin-coated filter and the conventional filter will be compared by means of statistical tests. The hypothesis is that the pre-heparin-coated filter induces significantly less clot score in the extracorporeal system during hemodialysis and also significantly less intravascular activation of the coagulation system compared to the conventional filter.

Eligibility criteria: Inclusion Criteria:

* Stable HD patients of at least 18 years of age.
* HD treatment for at least one month.
* Dialysis time at least 4 hours three times per week.
* Stable Hemoglobin value of at least 11 g/dl during the last 4 weeks.

Exclusion Criteria:

* Use of warfarin and/or acetylsalicylic acid.
* Disseminated malignant disease.
* Clinical signs of infection.

Primary outcomes:
measure: Activation of the intravascular coagulation system during hemodialysis with use of a pre-heparin-coated filter compared to a conventional filter
timeFrame: Activation of the intravascular coagulation system is assessed during four dialysis sessions within a two weeks period for a single patient
Secondary outcomes:
measure: A secondary outcome measure is degree of clot score in the extracorporeal system during hemodialysis with use of a pre-heparin-coated filter compared to the conventional filter.
timeFrame: The degree of clot score in the extracorporeal system is assessed during four hemodialysis sessions that for a single patient take place within a time frame of two weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of nephrology, Oslo University Hospital, Ullevål
Study officials:
affiliation: Oslo University hospital, Ullevål
name: Solbjørg Sagedal, PhD
role: PRINCIPAL_INVESTIGATOR
References: