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Trial registered on ANZCTR


Registration number
ACTRN12615000315516
Ethics application status
Approved
Date submitted
17/02/2015
Date registered
7/04/2015
Date last updated
15/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Factor concentrates versus Allogeneic blood in CardioThoracic Surgery trial
Scientific title
The influence of factor concentrates in comparison to allogeneic blood for haemostatic resuscitation in cardiac surgery on red cell transfusion rate and associated perioperative morbidities.
Secondary ID [1] 286193 0
HP TRIM Document : D/2015/9001
Universal Trial Number (UTN)
Trial acronym
FACTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery 294223 0
Blood transfusion 294224 0
Condition category
Condition code
Surgery 294543 294543 0 0
Other surgery
Anaesthesiology 294544 294544 0 0
Other anaesthesiology
Cardiovascular 294758 294758 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention arm will consist of haemostatic resuscitation comprising the use of factor concentrates, specifically a prothrombin complex concentrate (Prothrombinex-VF) and fibrinogen concentrate (RiaSTAP) titrated to point of care viscoelastic testing. Haemostatic therapy will applied when there is clinically documented bleeding (either >60g net weight intraoperatively or >100ml/hr mediastinal drain blood loss) and dosed according to the formulae 1. Fibrinogen concentrate (RiaSTAP) dose = ((12-A10 on FibTEM assay) x body weight)/140 and 2. Prothrombin concentrate in aliquots of 15U/kg if the clotting time (CT) on the ROTEM ExTEM is >90seconds or HepTEM is >240seconds. Both intervention and comparator arms will receive platelet transfusion is there is clinical bleeding and the absolute platelet count is <100 x10^9 or there is a qualitative defect documented on Multiple electrode aggregometry ADPtest, TRAPtest or ASPItest assays.
Intervention code [1] 291207 0
Treatment: Other
Comparator / control treatment
In the comparator arm, haemostatic resuscitation will be made using allogeneic blood products such as fresh frozen plasma and cryoprecipitate in approximate equipotent factor doses, titrated to identical point of care assay endpoints. In the presence of documented bleeding (either >60g net weight intraoperatively or >100ml/hr mediastinal drain blood loss) Haemostatic resuscitation will consist of 1. Cryoprecipitate as a source of fibrinogen which will be dosed in 4U aliquots until the A10 value on the FibTEM assay is >12mm and 2. FFP as a source of thrombin generation in doses of 15ml/kg (approximately 2 units) until the clotting time on the ROTEM ExTEM is <90seconds or HepTEM is <240seconds.
Control group
Active

Outcomes
Primary outcome [1] 294322 0
The Primary outcome will be red cell transfusion rate (i.e. number of red cell units per hour) and total amount, including rate of avoidance of requirement for transfusion as measured as a comparison of those not requiring transfusion in both the intervention and comparator arms.
Timepoint [1] 294322 0
Over the course of admission for surgery.
Secondary outcome [1] 313041 0
New onset atrial fibrillation - presence or absence
Timepoint [1] 313041 0
Over the course of admission for surgery.
Secondary outcome [2] 313535 0
Acute kidney injury by RIFLE criteria and need for renal replacement therapy
Timepoint [2] 313535 0
Over the course of admission for surgery.
Secondary outcome [3] 313536 0
Post operative mediastinal blood loss - ml per hour and totals at 6 hours, 24 hours and total drain output
Timepoint [3] 313536 0
Over the course of admission for surgery.
Secondary outcome [4] 313537 0
Rate of return to operating theatre for investigation of bleeding
Timepoint [4] 313537 0
Over the course of admission for surgery.
Secondary outcome [5] 313538 0
Mortality - as a percentage of total cases
Timepoint [5] 313538 0
Over the course of admission for surgery.
Secondary outcome [6] 313539 0
Embolic stroke - documented either by Head CT or MRI
Timepoint [6] 313539 0
Over the course of admission for surgery.
Secondary outcome [7] 313540 0
Vascular graft failure - confirmed by coronary catheter study within six months of the operation
Timepoint [7] 313540 0
Over the course of admission for surgery.
Secondary outcome [8] 313541 0
Deep Venous thrombosis - confirmed by lower limb venous duplex
Timepoint [8] 313541 0
Over the course of admission for surgery.
Secondary outcome [9] 313542 0
Pulmonary embolism - confirmed by CT pulmonary angiography or Ventilation/Perfusion scan
Timepoint [9] 313542 0
Over the course of admission for surgery.

Eligibility
Key inclusion criteria
All adult patients, aged 18 and over, presenting for cardiac surgery at St Vincent’s Hospital capable of giving consent, including solid organ transplantation and patients presenting for surgery on the antiplatelet agents aspirin and/or clopidogrel and/or the anticoagulant warfarin.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Documented haemostatic disease such as Haemophilia or Von Willebrands Disease; Incapable of consent; Surgery to involve placement of a ventricular assist device either left of right sided; Known history of deep venous thrombosis, pulmonary embolism or prothrombotic disorder such as antiphospholipid syndrome; Preoperative use of an antiplatelet agent or anticoagulant other than those allowed in the inclusion criteria, such as a direct thrombin antagonist, eg dabigatran or a different antiplatelet agent such as ticagrelor.

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)
Prospective randomised controlled trial – non-blinded - central randomisation by a computer stored in Intensive Care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (Adaptive/Stratified) randomisation will be used to allow for equal allocation of “high risk transfusion” patients as determined by the TRUST score.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The Transfusion Risk Understanding Scoring Tool (TRUST) will be used to assess clinical risk of transfusion. (Alghamdi, Davis, Brister, & Corey, 2006).
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Depending on the distribution of the data, either medians with interquartile ranges will be compared with a rank sum test or if the data is normally distributed using student's t-test. Based on the current St Vincent’s transfusion mean rate of 4.5U and targeting a reduction to 3.6U (ie 20%) which was achieved in the recent prospective trial of POC targeted therapy (Weber et al., 2012), we will require a minimum of 140 patients assuming a high level of variance in transfusion practise. This assumes a comparable level of variation to the German data (Weber et al., 2012) with a standard deviation of 3.8U. An interim analysis will be planned at 50 patients to assess safety and efficacy and to further refine sample and power size calculations according to the actual transfusion rates which will more than likely reduce during the study. Randomisation will be adjusted during the course of the study to attempt even allocation of high risk patients as determined using the TRUST tool. (Alghamdi et al., 2006)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3468 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 290770 0
Hospital
Name [1] 290770 0
St Vincent's and Mater Health Sydney
Country [1] 290770 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's and Mater Health Sydney
Address
390 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 289454 0
None
Name [1] 289454 0
Address [1] 289454 0
Country [1] 289454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292401 0
St Vincent's Hospital Research Office
Ethics committee address [1] 292401 0
Ethics committee country [1] 292401 0
Australia
Date submitted for ethics approval [1] 292401 0
09/02/2015
Approval date [1] 292401 0
10/02/2015
Ethics approval number [1] 292401 0
HREC/14/SVH/418

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

Contacts
Principal investigator
Name 54998 0
Dr David Lowe
Address 54998 0
Department of Intensive Care
St Vincent's Hospital Sydney
390 Victoria Street
Darlinghurst NSW 2010
Country 54998 0
Australia
Phone 54998 0
+61283821111
Fax 54998 0
Email 54998 0
david.lowe@svha.org.au
Contact person for public queries
Name 54999 0
David Lowe
Address 54999 0
Department of Intensive Care
390 Victoria Street
St Vincent's Hospital Sydney
Darlinghurst NSW 2010
Country 54999 0
Australia
Phone 54999 0
+61283821111
Fax 54999 0
Email 54999 0
david.lowe@svha.org.au
Contact person for scientific queries
Name 55000 0
Bruce Cartwright
Address 55000 0
Department of Anaesthesia
St Vincent's Hospital Sydney
390 Victoria Street
Darlinghurst NSW 2010
Country 55000 0
Australia
Phone 55000 0
+61283821111
Fax 55000 0
Email 55000 0
bruce.cartwright@sydney.edu.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.