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Hemodialysis Without Anticoagulation in Intensive Care Unit

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Centre Hospitalier Départemental.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00242398
First Posted: October 20, 2005
Last Update Posted: October 3, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Départemental
  Purpose
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

Condition Intervention Phase
Kidney Failure Critically Ill Hemorrhage Device: AN69 ST Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Départemental:

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

Estimated Enrollment: 120
Study Start Date: October 2005
Estimated Study Completion Date: April 2008
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242398


Contacts
Contact: Laurent Martin-Lefèvre, MD 33(0)251446088 laurent.martin-lefevre@chd-vendee.fr

Locations
France
CHD Recruiting
La Roche sur Yon, France, 85925
Contact: Laurent Martin-Lefevre         
Principal Investigator: Laurent Martin-Lefèvre         
Sponsors and Collaborators
Centre Hospitalier Départemental
Investigators
Principal Investigator: Laurent Martin-Lefèvre
  More Information

ClinicalTrials.gov Identifier: NCT00242398     History of Changes
Other Study ID Numbers: HDI-FH
First Submitted: October 18, 2005
First Posted: October 20, 2005
Last Update Posted: October 3, 2007
Last Verified: October 2007

Keywords provided by Centre Hospitalier Départemental:
Intensive care unit
Patients with bleeding high risk
Intermittent hemodialysis without anticoagulation
Blood lost

Additional relevant MeSH terms:
Hemorrhage
Critical Illness
Renal Insufficiency
Pathologic Processes
Disease Attributes
Kidney Diseases
Urologic Diseases