ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000985886p

Ethics application status

Submitted, not yet approved

Date submitted

22/06/2021

Date registered

27/07/2021

Date last updated

28/06/2022

Date data sharing statement initially provided

27/07/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Impact of perfusion with Methylene Blue on perioperative bleeding in simultaneous pancreas kidney transplant recipients

Scientific title

Impact of perfusion with Methylene Blue on perioperative bleeding in simultaneous pancreas kidney transplant recipients

Secondary ID [1]

N/A

Universal Trial Number (UTN)

N/A

Trial acronym

N/A

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Simultaneous Pancreas and Kidney Transplantation

Intraoperative Bleeding

Condition category

Condition code

Surgery

Surgical techniques

Renal and Urogenital

Kidney disease

Renal and Urogenital

Other renal and urogenital disorders

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The randomisation will be to either standard Soltran flush or Methylene Blue flush. If methylene blue is to be used then 0.5mL (5mg) of the methylene blue (50mg/5mL) solution will be diluted in a 1-litre bag of the Soltran solution, with approximately 300mL flushed through the pancreas. The flush will occur via a 'tips cannula' inserted into the arterial Y graft (donor SMA and splenic artery anastomosed to donor internal iliac artery and external iliac artery). Therefore, the overall dose will be ~0.15mL.

NB: International approved name is Methylene Blue manufactured by Phebra

All use will be monitored throughout by the surgical team and the research team will collect data following the procedure. This will be regularly audited throughout the research project to ensure safe practice is being upheld.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Prevention

Comparator / control treatment

Approximately 300mL of standard soltran flush, which is the Baxter Soltran Kidney Perfusion Solution containing. Each 1000mL contains:
- Potassium Citrate 8.6g, ~80mmol of potassium
- Sodium Citrate 8.2g, ~34mmol of sodium
- Mannitol BP 22.8g
- Magnesium Sulphate 10.0g, ~41mmol of magnesium and ~41mmol of sulphate
NB citrate concentration ~54mmol, the osmolarity is ~466mmol and the pH ~7.1

The Soltran solution will be administered and adherence monitored in the same manner as the Methylene Blue solution

Control group

Placebo

Outcomes

Primary outcome [1]

Impact on intra-operative bleeding assessed by data linkage to medical records (estimated intra-operative blood loss (amount in suction canister, weight of sponges, with amount of wash used subtracted).

Timepoint [1]

During pancreas-kidney transplantation

Secondary outcome [1]

Postoperative haematoma formation, measured via postoperative ultrasounds +/- need for return to theatre for evacuation and assessed via access by data linkage to medical records.

Timepoint [1]

Within first 12 months post pancreas-kidney transplantation

Secondary outcome [2]

Postoperative transfusion requirements measured via number of units transfused and monitoring haemoglobin and assessed via access by data linkage to medical records.

Timepoint [2]

Within 12 months of pancreas-kidney transplantation

Secondary outcome [3]

Mortality rate

Timepoint [3]

Within 3 months of pancreas-kidney transplantation

Eligibility

Key inclusion criteria

All donor pancreases used for a SPK transplant at Westmead Hospital and only participants who provide informed consent will be enrolled in the study.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria is any patients with previous adverse reactions or anaphylaxis to Methylene Blue and those who are being re-transplanted.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by computer using the REDCAP platform

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data will be expressed as the mean + standard deviation (SD), median with range, or n (%), as appropriate. Differences among continuous and categorical variables will be examined for statistical significance using the Student t test (or Mann-Whitney’s test) and the chi-squared test (or Fisher’s exact test). Univariate and Multivariate Cox regression will be performed to identify prognostic features for outcomes after pancreas transplantation (including overall survival, graft survival, blood loss, transfusion requirements, etc). The statistically significant level will be p < 0.05, and all analysis will be processed by SPSS (version 23).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/08/2022

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

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Westmead Hospital

Address [1]

Corner Hawkesbury Road & Darcy Road Westmead, NSW 2145

Country [1]

Australia

Primary sponsor type

Hospital

Name

Westmead Hospital

Address

Corner Hawkesbury Road & Darcy Road Westmead, NSW 2145

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Western Sydney Local Health District HREC

Ethics committee address [1]

Corner Hawkesbury Road & Darcy Road Westmead, NSW, 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/06/2021

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

For patients that undergo pancreas and kidney transplantation there is a risk of bleeding during and after the operation, one way of reducing this is identifying potential sources of bleeding during the preparation of the organ before we implant it into the patient. One solution called Methylene Blue can highlight these sources of bleeding, therefore we will want to conduct a research project to determine if this will reduce the risk of bleeding.

Trial website

N/A

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Henry Pleass

Address

Department of Surgery, Westmead Hospital, Corner Hawkesbury Road & Darcy Road Westmead, NSW, 2145

Country

Australia

Phone

+61 400219209

Fax

[email protected]

Contact person for public queries

Name

Henry Pleass

Address

Department of Surgery, Westmead Hospital, Corner Hawkesbury Road & Darcy Road Westmead, NSW, 2145

Country

Australia

Phone

+61 400219209

Fax

[email protected]

Contact person for scientific queries

Name

Henry Pleass

Address

Department of Surgery, Westmead Hospital, Corner Hawkesbury Road & Darcy Road Westmead, NSW, 2145

Country

Australia

Phone

+61 400219209

Fax

[email protected]

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
12203	Study protocol					382254-(Uploaded-22-06-2021-18-19-40)-Study-related document.docx

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.

Trial Review

Documents added manually

Documents added automatically