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

NCT01388270 | Completed Phase 4

• 1 other identifier: 2010/3019-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Activation of the intravascular coagulation system during hemodialysis with use of a pre-heparin-coated filter compared to a conventional filter

  Blood specimens for analysis of prothrombin fragment 1+2 and beta-thromboglobulin will be drawn at start of hemodialysis and after three and four hours of all hemodialysis sessions.

  Activation of the intravascular coagulation system is assessed during four dialysis sessions within a two weeks period for a single patient

Secondary Outcomes (1)

• 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.

  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

Study Arms (2)

Evodial

ACTIVE COMPARATOR

a pre-heparin-coated hemodialysis filter

Device: a pre-heparin-coated hemodialysis filter; Hepran

170 H

NO INTERVENTION

Conventional filter

Interventions

a pre-heparin-coated hemodialysis filter; Hepran DEVICE

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

Also known as: HeprAN membrane, polyacrylonitrile, heparin-grafted membrane

Evodial

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of nephrology, Oslo University Hospital, Ullevål

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

Renal Insufficiency; Thrombosis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Solbjørg Sagedal, PhD

  Oslo University hospital, Ullevål

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 6, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

NO (1)