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/study/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
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
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
Government body
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00214656