NCT00256100

Brief Summary

The purpose of this project is to assess the safety and effectiveness of fondaparinux, a new drug to prevent blood clotting in the continuous dialysis machine used in intensive care patients who have kidney failure.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2015

Enrollment Period

3.5 years

First QC Date

November 17, 2005

Last Update Submit

April 10, 2017

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

  • The study will evaluate the duration of filter patency using fondaparinux as an anticoagulant in haemofiltration and compare this to the current standard haemofilter anticoagulant, enoxaparin.

    Duration of the haemofilter life

Secondary Outcomes (1)

  • To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting.

    Until hospital discharge

Study Arms (2)

One

ACTIVE COMPARATOR

Enoxaparin Sodium (Clexane ) is to be used in the control arm of the study

Drug: Fondaparinux Sodium

Two

ACTIVE COMPARATOR

Fondaparinux will be used as the anticoagulant in the sencond arm of the study

Drug: Fondaparinux Sodium

Interventions

Fondaparinux SodiumDRUG

The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation

Also known as: Arixtra
OneTwo

Eligibility Criteria

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

You may qualify if:

  • Adult patients (18 years or over) admitted to the ICU and expected to stay for more than 48 hours.
  • Patients who require continuous renal replacement therapy.

You may not qualify if:

  • Patients aged less than 18 years of age.
  • Patients who are pregnant
  • Patients with a contraindication to anticoagulation for pre existing bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Melbourne Hospital Intensive Care Unit Grattan Street

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

OligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • John F Cade

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2005

First Posted

November 21, 2005

Study Start

June 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 12, 2017

Record last verified: 2015-04

Locations

AU(1)