Clinical trial NCT00242398: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Kidney Failure
Critically Ill
Hemorrhage
Keywords: Intensive care unit
Patients with bleeding high risk
Intermittent hemodialysis without anticoagulation
Blood lost
Lead sponsor: Centre Hospitalier Départemental
Sponsor class: OTHER
First posted: 2005-10-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Early stop dialysis treatment for rapid and persistent elevations in venous extracorporeal pressure secondary to extracorporeal thrombosis.
timeFrame: at the end of the dialysis treatement
Secondary outcomes:
measure: Blood lost associated with extracorporeal thrombosis or active bleeding
timeFrame: At the end of the dialysis treatment
measure: Necessary time of nurse's work
timeFrame: During the dialysis treatment
measure: Weight lost patients during dialysis treatment
timeFrame: At the end of dialysis treatment
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: CHD
Study officials:
name: Laurent Martin-Lefèvre
role: PRINCIPAL_INVESTIGATOR
References: