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