MedTrace Logo

"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery

NCT00214656 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2005-09-22

No results posted yet for this study

Summary

Aims and Hypotheses:

This randomised placebo controlled study will test the hypothesis that Recombinant Activated Factor VII (rVIIa) will improve haemostasis after an inadequate response to conventional therapy in complex cardiac surgery.

Major bleeding is still of concern in complex cardiac surgery. It has been shown to be associated with poorer patient outcome and results in the consumption of resources (hospital costs, manpower and blood bank reserves). This study has the potential to provide evidence that rVIIa can reduce transfusion requirements and improve patient outcome in a problematic aspect of complicated cardiac surgery.

The objective is to conduct a multi-centre randomised placebo controlled study that has been designed to scientifically evaluate the treatment of post bypass coagulopathy in the association with complex cardiac surgery. The trial design is based on clinical practice that has evolved over 2 years at the Austin Hospital during which 38 patients have received open label administration of rVIIa. There is currently no published RCT in this area and there is no TGA approval for the use of rVIIa for this indication.

Conditions

Interventions

DRUG

Recombinant Activated Factor VII

Sponsors & Collaborators

  • Austin Health

    lead OTHER_GOV

Principal Investigators

  • Peter McCall, FANZCA · Staff Anaesthetist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Completion
2008-06-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00214656 on ClinicalTrials.gov