Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001279718
Ethics application status
Approved
Date submitted
13/11/2013
Date registered
20/11/2013
Date last updated
16/12/2020
Date data sharing statement initially provided
19/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Prothrombinex or Fresh Frozen Plasma for Cardio Pulmonary Bypass Associated Bleeding (POPCAB)
Scientific title
For patients who experience bleeding after cardiopulmonary bypass, will treatment with Prothrombinex VF as compared to treatment with Fresh Frozen Plasma, decrease the rate of red cell and platelet transfusions?
Secondary ID [1] 283579 0
Nil
Universal Trial Number (UTN)
U1111-1150-2119
Trial acronym
POPCAB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-surgical bleeding after cardiopulmonary bypass 290482 0
Condition category
Condition code
Blood 290874 290874 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Human 3 Factor Prothrombin complex concentrate (Prothrombinex VF) 25IU/kg IV bolus for the first line treatment of non surgical bleeding post cardiopulmonary bypass.
Intervention code [1] 288267 0
Treatment: Drugs
Comparator / control treatment
Active control: Fresh Frozen Plasma 15ml/kg bolus IV as first line treatment for the treatment of non-surgical bleeding post cardiopulmonary bypass.
Control group
Active

Outcomes
Primary outcome [1] 290867 0
The composite end point of those patients receiving either allogeneic red blood cells or platelets after 15ml/kg FFP or Prothrombinex 25IU/kg
Timepoint [1] 290867 0
Up to 24 hours post operation
Primary outcome [2] 290868 0
The total cost of treatment following randomisation, which will include, drugs, procedures, imaging, length of stay in ICU and hospital. We will also include best estimation of blood product costs.
Timepoint [2] 290868 0
During hospital stay
Secondary outcome [1] 305499 0
Incidence of thrombotic complications defined by CHADx groups:
5.2 (pulmonary embolism) and 5.8 Venous thrombosis/embolism(not progressing to PE)
Assessment will be clinical and based on discharge coding.
Timepoint [1] 305499 0
At hospital discharge
Secondary outcome [2] 305500 0
Respiratory indices (P:F ratios)
Timepoint [2] 305500 0
at 6 and 12 hrs post op
Secondary outcome [3] 305501 0
Overall mortality
Timepoint [3] 305501 0
at 30 days
Secondary outcome [4] 305502 0
Length of stay in ICU and Hospital
Timepoint [4] 305502 0
At discharge from hospital
Secondary outcome [5] 305503 0
Chest drain output
Timepoint [5] 305503 0
6 and 24 hours
Secondary outcome [6] 305504 0
ICU arrival haemoglobin
Timepoint [6] 305504 0
On ICU arrival
Secondary outcome [7] 305505 0
Total surgical red cell loss (Mercuriali formula)
Timepoint [7] 305505 0
Post operative day 5

Eligibility
Key inclusion criteria
Patients undergoing cardiac surgery requiring cardiopulmonary bypass and determined to have non surgical bleeding post heparin reversal.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following patient groups will be excluded:
1.Patients with pre-existing bleeding diatheses
2.Patients receiving Prothrombinex or FFP less than 5 days before CPB
3.Patients receiving heart or lung transplant
4.Patients having implantation of ventricular assist devices (VAD’s)

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
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2015
Actual
2/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
122
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14590 0
Mount Hospital - Perth
Recruitment hospital [2] 14591 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 27609 0
6000 - Perth
Recruitment postcode(s) [2] 27610 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 288256 0
Government body
Name [1] 288256 0
WA State Health Research Advisory Committee
Country [1] 288256 0
Australia
Primary sponsor type
Individual
Name
Dr Warren Pavey
Address
Fiona Stanley Hospital
Anaesthetic Department Level 2 Main Building
11 Robin Warren Drive
MURDOCH WA 6150
Country
Australia
Secondary sponsor category [1] 286974 0
None
Name [1] 286974 0
Address [1] 286974 0
Country [1] 286974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290157 0
South Area Metropolitan Health Service (FSH)
Ethics committee address [1] 290157 0
Ethics committee country [1] 290157 0
Australia
Date submitted for ethics approval [1] 290157 0
15/11/2013
Approval date [1] 290157 0
12/10/2018
Ethics approval number [1] 290157 0
V4.3 210517
Ethics committee name [2] 304124 0
The Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [2] 304124 0
Ethics committee country [2] 304124 0
Australia
Date submitted for ethics approval [2] 304124 0
15/11/2013
Approval date [2] 304124 0
20/11/2014
Ethics approval number [2] 304124 0
REG 14-161
Ethics committee name [3] 304125 0
The University of Notre Dame Australia
Ethics committee address [3] 304125 0
Ethics committee country [3] 304125 0
Australia
Date submitted for ethics approval [3] 304125 0
24/01/2015
Approval date [3] 304125 0
16/03/2015
Ethics approval number [3] 304125 0
015009F

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

Contacts
Principal investigator
Name 44258 0
Dr Warren Pavey
Address 44258 0
Department of Anaesthesia
Fiona Stanley Hospital
Level 2 Main Building
11 Robin Warrren Drive
MURDOCH WA 6150
Country 44258 0
Australia
Phone 44258 0
+61 430389600
Fax 44258 0
Email 44258 0
[email protected]
Contact person for public queries
Name 44259 0
Warren Pavey
Address 44259 0
Department of Anaesthesia
Fiona Stanley Hospital
Level 2 Main Building
11 Robin Warrren Drive
MURDOCH WA 6150
Country 44259 0
Australia
Phone 44259 0
+61 430389600
Fax 44259 0
Email 44259 0
[email protected]
Contact person for scientific queries
Name 44260 0
Warren Pavey
Address 44260 0
Department of Anaesthesia
Fiona Stanley Hospital
Level 2 Main Building
11 Robin Warrren Drive
MURDOCH WA 6150
Country 44260 0
Australia
Phone 44260 0
+61 430389600
Fax 44260 0
Email 44260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbasePro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia.2018https://dx.doi.org/10.1002/14651858.CD010649.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.