Hemodialysis Without Anticoagulation in Intensive Care Unit

October 2, 2007 updated by: Centre Hospitalier Départemental

Heparin Free Hemodialysis for Patients With Bleeding High Risk in ICU. Randomized Study: Heparin Free Dialysis With Intermittent Saline Flushes Versus Heparin Free Dialysis With Nephral 400ST (AN69ST, Hospal, France)

The purpose of this study is to determine the safety and operative efficacy of intermittent hemodialysis without anticoagulation with saline flushes or Nephral 400ST in patients at high risk of bleeding

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Device: AN69 ST

Detailed Description

Hemodialysis in patients who are at high risk of bleeding complications represents a challenge of balancing the needs for establishment of an adequately functioning extracorporeal circuit for dialytic therapy with the requirement of not exacerbating existing bleeding or precipitating bleeding in predisposed subjects.

Several methods of nonheparin dialysis have been used. The method most commonly used to effect such treatment is "saline flushing": saline boluses are delivred at frequent intervals. This method is far from optimal for several reasons, including failure to maintain a patent circuit in significant proportion of patients, an added logistic burden on dialysis nurses. An alternative method of avoiding systemic heparinization is priming the dialysis membrane with heparin before hemodialysis. The method is based on fact that AN69ST (Nephral 400ST , Hospal, France) dialysis membrane have a high affinity for binding heparin, and that the bound heparin exerts a localized antithrombotic effect without systemic spillover.

Comparison: heparin free hemodialysis with saline flushes compared heparin free hemodialysis with Nephral 400ST.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - La Roche sur Yon, France, 85925
    - Recruiting
    - CHD
    - Contact:
      
      Laurent Martin-Lefevre
    - Principal Investigator:
      
      Laurent Martin-Lefèvre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

age > 18 years
patient with high risk bleeding
patient requiring dialytic therapy in intensive care unit

Exclusion Criteria:

Pregnancy
History of heparin-induced thrombocytopenia or serious heparin allergy
History of serious membrane dialysis allergy
Treatment by any of following medications 24H within the inclusion:

prophylactic or therapeutic anticoagulation with unfractioned heparin or low molecular weight heparin nonsteroidal anti-inflammatory agents direct thrombin inhibitors, antithrombin concentrate, activated protein C, anti-factor Xa pentasaccharide

Treatement by acetylsalicylic acid or other antiplatelet agent excluding platelet glycoprotein IIb/IIIa antagonists 7 days within the inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Early stop dialysis treatment for rapid and persistent elevations in venous extracorporeal pressure secondary to extracorporeal thrombosis. Time Frame: at the end of the dialysis treatement	at the end of the dialysis treatement

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood lost associated with extracorporeal thrombosis or active bleeding Time Frame: At the end of the dialysis treatment	At the end of the dialysis treatment
Necessary time of nurse's work Time Frame: During the dialysis treatment	During the dialysis treatment
Weight lost patients during dialysis treatment Time Frame: At the end of dialysis treatment	At the end of dialysis treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Départemental

Investigators

Principal Investigator: Laurent Martin-Lefèvre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (ANTICIPATED)

April 1, 2008

Study Registration Dates

First Submitted

October 18, 2005

First Submitted That Met QC Criteria