ANZCTR - Registration

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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

7/12/2020

Date data sharing statement initially provided

7/12/2020

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]

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

Peritoneal cancer

Condition category

Condition code

Surgery

Other surgery

Cancer

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]

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]

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]

24 hours post surgery

Primary outcome [2]

Reduction in the number of units of blood products transfused in the first 24 hours, including the time of surgery.

Timepoint [2]

24 hours post surgery

Secondary outcome [1]

Measured blood loss and other fluid loss (cell saver, etc). This will be assessed by visual assessment.

Timepoint [1]

24 hours post surgery

Secondary outcome [2]

Volume of other fluids received

Timepoint [2]

During surgery

Secondary outcome [3]

Requirement for take-back to operating theatre (OT) to control bleeding within 7 days of surgery

Timepoint [3]

Within 7 days of surgery

Secondary outcome [4]

Thrombotic events to be recorded as adverse events

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

1/11/2012

Actual

8/10/2013

Date of last participant enrolment

Anticipated

Actual

28/02/2017

Date of last data collection

Anticipated

Actual

13/11/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St George Public Hospital

Address [1]

Gray St, Kogarah, NSW 2217

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Australian New Zealand Society of Blood Transfusion

Address [2]

145 Macquarie St,
Sydney NSW 2000

Country [2]

Australia

Primary sponsor type

Hospital

Name

St George Hospital

Address

Gray St, Kogarah, NSW 2217

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SESLHD Human Research Ethics Committee (Southern Sector)

Ethics committee address [1]

St George and sutherland Hospital research Office,
Level 3 James Law House, St George Hospital, Gray St, Kogarah NSW 2217

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/02/2012

Ethics approval number [1]

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

Presented at HSANZ Annual Scientific Meeting Oct 2018

Public notes

Contacts

Principal investigator

Name

Dr Shir Jing Ho

Address

Lvl 4 Clinical Services Building, St George Hospital, Gray St, Kogarah, NSW 2217

Country

Australia

Phone

+61 414835018

Fax

shirjing.ho@health.nsw.gov.au

Contact person for public queries

Name

Ms Roslyn Ristuccia

Address

St George Hospital Clinical Trials Unit, Ground FLoor, Pitney Building, St George Hospital, Gray St, Kogarah, NSW 2217

Country

Australia

Phone

61 2 91132977

Fax

61 2 91132960

RistucciaR@sesiahs.health.nsw.gov.au

Contact person for scientific queries

Name

Shir-Jing Ho

Address

Department of Haematology,
St George Hospital, Gray st, Kogarah NSW 2217

Country

Australia

Phone

61 2 91133851

Fax

61 2 91133942

shirjing.ho@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9990	Study protocol			shirjing.ho@health.nsw.gov.au

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.

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