Skip to content

Hemodialysis Without Anticoagulation in Intensive Care Unit

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)

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00242398
Enrollment
120
Registered
2005-10-20
Start date
2005-10-31
Completion date
2008-04-30
Last updated
2007-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill, Hemorrhage, Kidney Failure

Keywords

Intensive care unit, Patients with bleeding high risk, Intermittent hemodialysis without anticoagulation, Blood lost

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.

Interventions

DEVICEAN69 ST

Sponsors

Centre Hospitalier Départemental
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Blood lost associated with extracorporeal thrombosis or active bleedingAt the end of the dialysis treatment
Necessary time of nurse's workDuring the dialysis treatment
Weight lost patients during dialysis treatmentAt the end of dialysis treatment

Countries

France

Contacts

Primary ContactLaurent Martin-Lefèvre, MD
laurent.martin-lefevre@chd-vendee.fr33(0)251446088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026