Viewing Study NCT00242398



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Last Modification Date: 2024-10-26 @ 9:20 AM
Study NCT ID: NCT00242398
Status: UNKNOWN
Last Update Posted: 2007-10-03
First Post: 2005-10-18

Brief Title: Hemodialysis Without Anticoagulation in Intensive Care Unit
Sponsor: Centre Hospitalier Départemental
Organization: Centre Hospitalier Départemental

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2007-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None