Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.

Renal Failure Clinical Trial

Official title:

Assessment of the Safety and Efficacy of Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Renal Failure.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00256100
• Other study ID #: 2004.066
• Status: Terminated
• Phase: N/A
• First received: November 17, 2005
• Last updated: April 10, 2017
• Start date: June 2004
• Est. completion date: December 2007

Study information

• Verified date: April 2015
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study hypothesis is that when used as an anticoagulant in haemofiltration, fondaparinux prolongs the filter life when compared to enoxaparin.

Fondaparinux is the first compound of a new class of synthetic oligosaccharides with antithrombotic effects. It represents the active portion of the natural heparin molecule.

The null hypothesis is that there is no difference in filter life when using fondaparinux or enoxaparin as anticoagulation for haemofiltration.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients (18 years or over) admitted to the ICU and expected to stay for more than 48 hours.

2. Patients who require continuous renal replacement therapy.

3. Patients who consent or if the patient is not competent, the next of kin who consent to inclusion in the study. .

Exclusion Criteria:

1. Patients aged less than 18 years of age.

2. Patients who are pregnant

3. Patients with a contraindication to anticoagulation for pre existing bleeding diathesis

4. Patients or next of kin who do not consent to study inclusion. -

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Fondaparinux Sodium
The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation

Locations

Country	Name	City	State
Australia	The Royal Melbourne Hospital Intensive Care Unit Grattan Street	Parkville	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting.		Until hospital discharge