NCT00242398

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

October 3, 2007

Status Verified

October 1, 2007

First QC Date

October 18, 2005

Last Update Submit

October 2, 2007

Conditions

Kidney FailureCritically IllHemorrhage

Keywords

Intensive care unitPatients with bleeding high riskIntermittent hemodialysis without anticoagulationBlood lost

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Blood lost associated with extracorporeal thrombosis or active bleeding

    At the end of the dialysis treatment

  • Necessary time of nurse's work

    During the dialysis treatment

  • Weight lost patients during dialysis treatment

    At the end of dialysis treatment

Interventions

AN69 STDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • patient with high risk bleeding
  • patient requiring dialytic therapy in intensive care unit

You may not qualify if:

  • Pregnancy
  • History of heparin-induced thrombocytopenia or serious heparin allergy
  • History of serious membrane dialysis allergy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHD

La Roche-sur-Yon, 85925, France

RECRUITING

MeSH Terms

Conditions

Renal InsufficiencyCritical IllnessHemorrhage

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laurent Martin-Lefèvre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Martin-Lefèvre, MD

CONTACT

33(0)251446088laurent.martin-lefevre@chd-vendee.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2005

First Posted

October 20, 2005

Study Start

October 1, 2005

Study Completion

April 1, 2008

Last Updated

October 3, 2007

Record last verified: 2007-10

Locations

FR(1)