Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000182695
Ethics application status
Approved
Date submitted
11/02/2014
Date registered
17/02/2014
Date last updated
21/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Critical Evaluation of a Targeted Point of Care (POC) ROTEM (Registered Trademark) and Multiplate (Registered Trademark) Guided Coagulation and Haemostasis Management Programme in Cardiac Surgical Patients
Scientific title
Critical Evaluation of a Targeted Point of Care (POC) ROTEM (Registered Trademark) and Multiplate (Registered Trademark) Guided Coagulation and Haemostasis Management Programme in Cardiac Surgical Patients
Secondary ID [1] 284076 0
N/A
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coagulation and transfusion management in patients undergoing cardiac surgery 291136 0
Condition category
Condition code
Blood 291476 291476 0 0
Clotting disorders
Surgery 291510 291510 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
ROTEM / Multiplate coagulation assessment and product transfusion protocol.
At 4 predefined time points a ROTEM/Multiplate panel of tests will be analysed:
1. Pre-operatively
2. 30 mins before coming off Cardiopulmonary Bypass
3. 10 mins after coming off CPB and after Protamine
4. On admission to ICU post-operatively

At each of these time points blood product replacement will be guided by the results. There is a predefined and validated algorithm.

In addition further tests will be done 10 minutes after any haemostatic intervention.

Further testing can be done at clinician discretion - i.e. In the presence of on-going bleeding further testing will be performed.

Testing will cease once there is no further evidence of on-going bleeding .
Intervention code [1] 288768 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291452 0
Blood and Blood Product Transfusion Rates
Timepoint [1] 291452 0
1 year
Secondary outcome [1] 306803 0
Blood and Blood Product Cost
This data will be accessed from GCUH Blood Bank database
Timepoint [1] 306803 0
1 year
Secondary outcome [2] 306804 0
Adverse Events Rate - TACO / TRALI / MOF / ARF / Sepsis
Timepoint [2] 306804 0
1 year
Secondary outcome [3] 306805 0
Mortality at 30 / 60 / 90 days
Timepoint [3] 306805 0
1 year
Secondary outcome [4] 306806 0
Disturbances in Fibrogen and Platelet contribution to coagulation in the preoperative period.
This is assessed by analysing the results of ROTEM/Multiplate tests.
Timepoint [4] 306806 0
1 year
Secondary outcome [5] 306807 0
Cardiac Functional Outcome:
Functional outcome - NYHA Class
Cardiac Function - Echocardiography at 6 weeks post-operatively
Timepoint [5] 306807 0
1 year

Eligibility
Key inclusion criteria
All patients undergoing cardiac surgery
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
De-identified data will be obtained from hospital managed patient records and results will be amalgamated into a customised secure excel spreadsheet. Prior to analysis data will be assessed for normality using Kolmogorov-Smirnov and Shapiro-Wilk tests. Blood test results at different time points will be analysed using repeated measures ANOVA and Bonferroni post hoc test. The association between pre/peri-operative carboxy-haemoglobin and total bilirubin with post-operative cardiac function will be determined using either Pearson or Spearman’s rank correlation. T-tests will test the effect of baseline (high or low) carboxy-haemoglobin/total bilirubin concentrations on event rates per person years (readmission, arrhythmia etc).

A prospective sample size calculation was performed based on decreased Fibrinogen level experienced post cardiac surgery for a desired power of 90% and a alpha of 5% a minimum total subject sample size of 26 patients is estimated. To ensure validity we propose to recruit a minimum of 100 patients.

Statistical Package for the Social Sciences (SPSS) will be used to perform the statistical analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
29/06/2015
Date of last participant enrolment
Anticipated
1/03/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2077 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 7769 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 288708 0
Hospital
Name [1] 288708 0
Gold Coast University Hospital
Country [1] 288708 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital Critical Care Research Group
Address
1 Hospital Boulevard
Southport
QLD
4215
Country
Australia
Secondary sponsor category [1] 287410 0
None
Name [1] 287410 0
Address [1] 287410 0
Country [1] 287410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290544 0
Gold Coast University Hospital HREC
Ethics committee address [1] 290544 0
Ethics committee country [1] 290544 0
Australia
Date submitted for ethics approval [1] 290544 0
12/02/2014
Approval date [1] 290544 0
26/03/2014
Ethics approval number [1] 290544 0
EC00160

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46182 0
Dr James Winearls
Address 46182 0
Gold Coast University Hospital
1 Hospital Boulevard
Southport
QLD
4215
Country 46182 0
Australia
Phone 46182 0
+61756875684
Fax 46182 0
Email 46182 0
james_winearls@health.qld.gov.au
Contact person for public queries
Name 46183 0
James Winearls
Address 46183 0
Gold Coast University Hospital
1 Hospital Boulevard
Southport
QLD
4215
Country 46183 0
Australia
Phone 46183 0
+61756875684
Fax 46183 0
Email 46183 0
james_winearls@health.qld.gov.au
Contact person for scientific queries
Name 46184 0
James Winearls
Address 46184 0
Gold Coast University Hospital1 Hospital Boulevard
Southport
QLD
4215
Country 46184 0
Australia
Phone 46184 0
+61756875684
Fax 46184 0
Email 46184 0
james_winearls@health.qld.gov.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.