Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis

NCT ID: NCT01388270

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-01-31

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.

Conditions

Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Evodial

a pre-heparin-coated hemodialysis filter

Group Type: ACTIVE_COMPARATOR

a pre-heparin-coated hemodialysis filter; Hepran

Intervention Type: DEVICE

Use of the pre-heparin-coated filter compared to the conventional filter in a cross over design

170 H

Conventional filter

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

a pre-heparin-coated hemodialysis filter; Hepran

Use of the pre-heparin-coated filter compared to the conventional filter in a cross over design

Intervention Type: DEVICE

Other Intervention Names

HeprAN membrane; polyacrylonitrile; heparin-grafted membrane

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Solbjørg Sagedal

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Solbjørg Sagedal, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University hospital, Ullevål

Locations

Department of nephrology, Oslo University Hospital, Ullevål

Oslo, , Norway

Countries

Norway

Other Identifiers

2010/3019-2

Identifier Type: -

Identifier Source: org_study_id