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Hemodialysis Without Anticoagulation in Intensive Care Unit

Primary Purpose

Kidney Failure, Critically Ill, Hemorrhage

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
AN69 ST
Sponsored by
Centre Hospitalier Départemental
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring Intensive care unit, Patients with bleeding high risk, Intermittent hemodialysis without anticoagulation, Blood lost

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHDRecruiting

Outcomes

Primary Outcome Measures

Early stop dialysis treatment for rapid and persistent elevations in venous extracorporeal pressure secondary to extracorporeal thrombosis.

Secondary Outcome Measures

Blood lost associated with extracorporeal thrombosis or active bleeding
Necessary time of nurse's work
Weight lost patients during dialysis treatment

Full Information

First Posted
October 18, 2005
Last Updated
October 2, 2007
Sponsor
Centre Hospitalier Départemental
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1. Study Identification

Unique Protocol Identification Number
NCT00242398
Brief Title
Hemodialysis Without Anticoagulation in Intensive Care Unit
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Départemental

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Critically Ill, Hemorrhage
Keywords
Intensive care unit, Patients with bleeding high risk, Intermittent hemodialysis without anticoagulation, Blood lost

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
AN69 ST
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Blood lost associated with extracorporeal thrombosis or active bleeding
Time Frame
At the end of the dialysis treatment
Title
Necessary time of nurse's work
Time Frame
During the dialysis treatment
Title
Weight lost patients during dialysis treatment
Time Frame
At the end of dialysis treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Martin-Lefèvre, MD
Phone
33(0)251446088
Email
laurent.martin-lefevre@chd-vendee.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Martin-Lefèvre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHD
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Martin-Lefevre
First Name & Middle Initial & Last Name & Degree
Laurent Martin-Lefèvre

12. IPD Sharing Statement

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Hemodialysis Without Anticoagulation in Intensive Care Unit

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