Reduction of Heparin Dose in Dialysis With Evodial System

NCT00781690 | Completed

• 2 other identifiers: 1456ISRCTN 93952087
• Study Type: interventional
• Target: 53
• Locations: 4 countries
• Sites: 7

Brief Summary

The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.

Conditions

Chronic Kidney Failure

Keywords

Chronic kidney failure; Heparin; Hemodialysis; Biocompatibility

Outcome Measures

Primary Outcomes (1)

• The primary criterion is the measurement of Anti Xa at the end of dialysis sessions.

  End of dialysis treatment

Secondary Outcomes (5)

• Follow-up of aPTT for patients treated with UFH,

  Kinetic on single dialysis treatment

• Evaluation of TAT (Thrombin-Antithrombin) complex,

  Kinetic on single dialysis treatment

• Follow-up of ionic clearance (Diascan) measurements during HD sessions,

  Kinetic of single dialysis treatment

• Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale,

  End of dialysis treatment

• Follow-up of AE/SAE.

  All treatments during study period

Study Arms (1)

1

EXPERIMENTAL

Treatment with Evodial with reduction of heparin across study period

Device: Evodial hemodialysers and Evodia blood lines

Interventions

Evodial hemodialysers and Evodia blood lines DEVICE

Maximum 8 weeks treatment with Evodial dialysers with reduction of heparin dose

1

Eligibility Criteria

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

You may qualify if:

• Patients suffering from chronic renal failure,
• Patients treated in HD three times a week for at least 3 months, with a stable heparin dose and the same filter,
• Patients treated in 4-4.5 hours HD mode with a blood flow between 300-350 ml/min,
• Patients for whom either LMWH (Enoxaparin, Nadroparin, Tinzaparin) or UFH is used,
• Patients with a well-functioning vascular access as judged by the investigator,
• Patients treated either on AK, Innova or Integra dialysis machines equipped with ionic dialysance device,
• Patients older than 18 years,
• Patients with negative serologies (AIDS, Hepatitis)
• Patients having signed consent to participate in the study.

You may not qualify if:

• Patient with HIT or known heparin allergy,
• Patient treated in HD in single needle mode,
• Patients with catheter,
• Patients with acute inflammatory event that may affect, as judged by investigator patients' safety or study results,
• Patients participating in other studies that could interfere with the objective of this study,
• Patients with active malignant disease,
• Patients receiving heparin outside dialysis treatment,
• Patients under guardianship,
• Pregnant women, nursing mothers and women planning a pregnancy during the course of this study,
• Patients with serious history of coagulopathy,
• Patients receiving Anti-Vitamin K medication,
• Patients receiving an association of anti platelets agents,
• Patients with heparin dose that can not be reduced for technical reason (excluding patients receiving too low heparin dose with no possibility of further reduction).

Sponsors & Collaborators

• Vantive Health LLC: lead
• Gambro Lundia AB: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (7)

Calydial dialysis unit

Irigny, 69540, France

Location

Clinique St Exupéry

Toulouse, 31400, France

Location

Hopital Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

ALTIR Dialysis center

Vandœuvre-lès-Nancy, France

Location

Medizinische Hochschule

Hanover, 30625, Germany

Location

Borgo Trento Hospital

Verona, Italy

Location

Karolinska Hospital

Stockholm, Sweden

Location

Related Publications (3)

• Lavaud S, Canivet E, Wuillai A, Maheut H, Randoux C, Bonnet JM, Renaux JL, Chanard J. Optimal anticoagulation strategy in haemodialysis with heparin-coated polyacrylonitrile membrane. Nephrol Dial Transplant. 2003 Oct;18(10):2097-104. doi: 10.1093/ndt/gfg272.

  PMID: 13679486 BACKGROUND

• Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. doi: 10.1093/ndt/gfm888. Epub 2007 Dec 21.

  PMID: 18156457 BACKGROUND

• Kessler M, Gangemi C, Gutierrez Martones A, Lacombe JL, Krier-Coudert MJ, Galland R, Kielstein JT, Moureau F, Loughraieb N. Heparin-grafted dialysis membrane allows minimal systemic anticoagulation in regular hemodialysis patients: a prospective proof-of-concept study. Hemodial Int. 2013 Apr;17(2):282-93. doi: 10.1111/j.1542-4758.2012.00733.x. Epub 2012 Aug 23.

  PMID: 22925178 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michèle Kessler, Pf

  Hopital Brabois, Vandoeuvre les Nancy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

DE (1); SE (1); IT (1); FR (4)