Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00214656




Registration number
NCT00214656
Ethics application status
Date submitted
14/09/2005
Date registered
22/09/2005
Date last updated
22/09/2005

Titles & IDs
Public title
"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery
Scientific title
"Salvage Use" of Recombinant Activated Factor VII After Inadequate Haemostatic Response to Conventional Therapy in Complex Cardiac Surgery - a Randomised Placebo Controlled Trial
Secondary ID [1] 0 0
H2005/02047
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Ischemia 0 0
Blood Coagulation Disorders 0 0
Coronary Artery Disease 0 0
Heart Valve Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Recombinant Activated Factor VII

Treatment: Drugs: Recombinant Activated Factor VII
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adequate haemostasis to enable chest closure after administration of trial medication without the need for further intervention to improve coagulation.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Percentage of cases that haemostasis after first administration of coagulation factors alone
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Assessment of surgical field after administration of trial medication
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Time to closure of chest after administration of trial medication
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Transfusion requirements in post bypass period in theatre
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Transfusion requirements in ICU first 12 hours
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Mediastinal drainage in ICU first 12 hours
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Coagulation study results at various sample times
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Requirement for chest re-exploration
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Ventilation duration in ICU
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Duration of stay in ICU
Timepoint [10] 0 0

Eligibility
Key inclusion criteria
- Patients with scheduled cardiac surgery undergoing the following procedures

- Double valve replacements or repair.

- Major thoracic aortic surgery including hypothermic circulatory arrest or descending
aortic reconstruction.

- Valve repair or replacement in the setting of endocarditis

- Complex procedures requiring cardiopulmonary bypass duration anticipated to exceed 180
minutes in patients aged ³70 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient unable to give informed consent

- Patient refusal

- Allergy to rVIIa

- Allergy to aprotinin or prior exposure within 6 months

- Pre-existing congenital coagulopathy

- Pre-existing hypercoagulable state

- Patients in inclusion criteria whose actual bypass time does not exceed 180 minutes

- Unresolved surgical bleeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00214656
Trial related presentations / publications
Hedner U, Erhardtsen E. Potential role for rFVIIa in transfusion medicine. Transfusion. 2002 Jan;42(1):114-24. doi: 10.1046/j.1537-2995.2002.00017.x. No abstract available.
Public notes

Contacts
Principal investigator
Name 0 0
Peter McCall, FANZCA
Address 0 0
Staff Anaesthetist
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Peter McCall, FANZCA
Address 0 0
Country 0 0
Phone 0 0
61 3 94965000
Fax 0 0
Email 0 0
peter.mccall@austin.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00214656