Hemodialysis Without Anticoagulation in Intensive Care Unit

Hemorrhage Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00242398
• Other study ID #: HDI-FH
• Status: Recruiting
• Phase: Phase 3
• First received: October 18, 2005
• Last updated: October 2, 2007
• Start date: October 2005
• Est. completion date: April 2008

Study information

• Verified date: October 2007
• Source: Centre Hospitalier Départemental
• Contact: Laurent Martin-Lefèvre, MD
• Phone: 33(0)251446088
• Email: laurent.martin-lefevre[@]chd-vendee.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Hemorrhage
• Kidney Failure
• Renal Insufficiency

Intervention

Device:
• AN69 ST

Locations

Country	Name	City	State
France	CHD	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Départemental

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early stop dialysis treatment for rapid and persistent elevations in venous extracorporeal pressure secondary to extracorporeal thrombosis.		at the end of the dialysis treatement
Secondary	Blood lost associated with extracorporeal thrombosis or active bleeding		At the end of the dialysis treatment
Secondary	Necessary time of nurse's work		During the dialysis treatment
Secondary	Weight lost patients during dialysis treatment		At the end of dialysis treatment