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Hemodialysis Without Anticoagulation in Intensive Care Unit

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Centre Hospitalier Départemental.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Départemental
ClinicalTrials.gov Identifier:
NCT00242398
First received: October 18, 2005
Last updated: October 2, 2007
Last verified: October 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00242398     History of Changes
Other Study ID Numbers: HDI-FH
Study First Received: October 18, 2005
Last Updated: October 2, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 16, 2013