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Trial registered on ANZCTR


Registration number
ACTRN12612001002875
Ethics application status
Approved
Date submitted
8/08/2012
Date registered
18/09/2012
Date last updated
21/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial to Compare Administration of Prothrombin Complex Concentrate with Standard Haemostasis Management in Adult Patients Undergoing Peritoneal Cytoreductive Surgery Requiring Massive Transfusion.
Scientific title
Efficacy of prothrombin complex in achieving haemostasis compared to standard treatment in adult patients undergoing peritoneal cytoreductive surgery requiring massive transfusion.
Secondary ID [1] 280793 0
Nil
Universal Trial Number (UTN)
U1111-1132-5054
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing peritoneal cytoreductive surgery 286852 0
Peritoneal cancer 287272 0
Condition category
Condition code
Surgery 287177 287177 0 0
Other surgery
Cancer 287598 287598 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients to receive early administration of prothrombin complex concentrate. It may be administered after surgery has commenced and based on the peritoneal carcinomatosis index (PCI) count, it is considered that the patient is at high risk of massive transfusion. Prothrombinex will be administered at a dose of 20IU/kg ( up to a maximum of 50IU/kg), given intravenously. The dose given will be at the discretion of the physician.
Intervention code [1] 285223 0
Treatment: Drugs
Comparator / control treatment
Patients will receive usual standard haemostasis management- this includes administration of blood products (FFP, cryoprecipitate) according to laboratory coagulation results.
Control group
Active

Outcomes
Primary outcome [1] 287471 0
Efficacy of Prothrombinex in achieving haemostasis compared to standard treatment. Achievement of haemostasis shall be defined as stable haematocrit and no increase in drain losses with blood.
Timepoint [1] 287471 0
24 hours post surgery
Primary outcome [2] 287472 0
Reduction in the number of units of blood products transfused in the first 24 hours, including the time of surgery.
Timepoint [2] 287472 0
24 hours post surgery
Secondary outcome [1] 298234 0
Measured blood loss and other fluid loss (cell saver, etc). This will be assessed by visual assessment.
Timepoint [1] 298234 0
24 hours post surgery
Secondary outcome [2] 298235 0
Volume of other fluids received
Timepoint [2] 298235 0
During surgery
Secondary outcome [3] 298236 0
Requirement for take-back to operating theatre (OT) to control bleeding within 7 days of surgery
Timepoint [3] 298236 0
Within 7 days of surgery
Secondary outcome [4] 298237 0
Thrombotic events to be recorded as adverse events
Timepoint [4] 298237 0
Within 7 days of surgery

Eligibility
Key inclusion criteria
1. Age greater than or equal to 18 years
2. Planned for peritonectomy
3. Informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known bleeding disorder
2. Known requirement for anti-coagulation e.g. prior DVT/PE requiring anti-coagulation, requirement for caval filter
3. Known hypersensitivity to any pooled-blood or recombinant blood products
4. Known hypersensitivity to any constituents in Prothrombinex-VF, including know allergy to heparin or a history of heparin-induced thrombocytopenia
5. Evidence of active thrombosis or disseminated intravascular coagulation (DIC)

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)
Eligible patients will be pre-consented for participation in the study prior . As only a proportion of patients will be eligible for randomization (as explained below in study procedures) and in view of the logistic impossibility of real-time consenting, patients will be pre-consented for participation prior to surgery. During surgery, and at the discretion of the surgical and anaesthetic teams, the patient will be determined to be suitable for randomisation based on their anticipated risk of massive transfusion. Eligible participants will be randomised to standard care or early use of Prothrombinex-VF.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation: If the patient is at risk of massive transfusion (as evaluated by the anaesthetist and surgeon), the patient will be randomised to either arm by contacting an independent data manager holding the code. The randomisation code will be one to one using variable block sizes to allocate the patient to either arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
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)
NSW

Funding & Sponsors
Funding source category [1] 285585 0
Hospital
Name [1] 285585 0
St George Public Hospital
Address [1] 285585 0
Gray St, Kogarah, NSW 2217
Country [1] 285585 0
Australia
Funding source category [2] 285586 0
Charities/Societies/Foundations
Name [2] 285586 0
Australian New Zealand Society of Blood Transfusion
Address [2] 285586 0
145 Macquarie St,
Sydney NSW 2000
Country [2] 285586 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Gray St, Kogarah, NSW 2217
Country
Australia
Secondary sponsor category [1] 284418 0
None
Name [1] 284418 0
Address [1] 284418 0
Country [1] 284418 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287592 0
SESLHD Human Research Ethics Committee (Southern Sector)
Ethics committee address [1] 287592 0
St George and sutherland Hospital research Office,
Level 3 James Law House, St George Hospital, Gray St, Kogarah NSW 2217
Ethics committee country [1] 287592 0
Australia
Date submitted for ethics approval [1] 287592 0
Approval date [1] 287592 0
10/02/2012
Ethics approval number [1] 287592 0

Summary
Brief summary
The purpose of this study is to investigate whether the early use of a blood clotting drug during peritonectomy surgery reduces the amount of bleeding that occurs and so reduces the amount of blood transfusion you may need. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo a peritonectomy. Trial details: Peritonectomy surgery is associated with a high risk of bleeding and many patients will require what is known as massive blood transfusion. This typically involves a transfusion of at least 10 units of blood or roughly your whole blood volume. In this research we hope to compare two treatments. Half the participants will receive the standard treatment used in this hospital. This involves the use of blood clotting factors and blood transfusion. In addition patients who have persistently high blood loss are sometimes given a treatment called recombinant factor VIIa. The other half of the participants will receive a product known as Prothrombinex-VF early in the operation when the anaesthetist suspects that there will be high blood loss. Prothrombinex-VF is a commercial product that contains blood clotting factors – these help the blood clot. All other treatment will be the same as usual practice. With this research we hope to be able to show that early use of Prothrombinex-VF reduces the need for blood transfusion and the overall need for blood products such as blood clotting factor preparations.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34403 0
Address 34403 0
Country 34403 0
Phone 34403 0
Fax 34403 0
Email 34403 0
Contact person for public queries
Name 17650 0
Ms Roslyn Ristuccia
Address 17650 0
St George Hospital Clinical Trials Unit, Ground FLoor, Pitney Building, St George Hospital, Gray St, Kogarah, NSW 2217
Country 17650 0
Australia
Phone 17650 0
61 2 91132977
Fax 17650 0
61 2 91132960
Email 17650 0
RistucciaR@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 8578 0
Shir-Jing Ho
Address 8578 0
Department of Haematology,
St George Hospital, Gray st, Kogarah NSW 2217
Country 8578 0
Australia
Phone 8578 0
61 2 91133851
Fax 8578 0
61 2 91133942
Email 8578 0
shir-jing.ho@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
No Results