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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
27/07/2021
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] 304587 0
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 322486 0
Intraoperative Bleeding 322791 0
Condition category
Condition code
Surgery 320124 320124 0 0
Surgical techniques
Renal and Urogenital 320382 320382 0 0
Kidney disease
Renal and Urogenital 320383 320383 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 320384 320384 0 0
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] 320939 0
Treatment: Drugs
Intervention code [2] 320940 0
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] 327997 0
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] 327997 0
During pancreas-kidney transplantation
Secondary outcome [1] 397211 0
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] 397211 0
Within first 12 months post pancreas-kidney transplantation
Secondary outcome [2] 398111 0
Postoperative transfusion requirements measured via number of units transfused and monitoring haemoglobin and assessed via access by data linkage to medical records.
Timepoint [2] 398111 0
Within 12 months of pancreas-kidney transplantation
Secondary outcome [3] 398112 0
Mortality rate
Timepoint [3] 398112 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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] 19788 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 34435 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 308952 0
Hospital
Name [1] 308952 0
Westmead Hospital
Address [1] 308952 0
Corner Hawkesbury Road & Darcy Road Westmead, NSW 2145
Country [1] 308952 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Corner Hawkesbury Road & Darcy Road Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 309873 0
None
Name [1] 309873 0
Address [1] 309873 0
Country [1] 309873 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308839 0
Western Sydney Local Health District HREC
Ethics committee address [1] 308839 0
Corner Hawkesbury Road & Darcy Road Westmead, NSW, 2145
Ethics committee country [1] 308839 0
Australia
Date submitted for ethics approval [1] 308839 0
22/06/2021
Approval date [1] 308839 0
Ethics approval number [1] 308839 0

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 112074 0
Prof Henry Pleass
Address 112074 0
Department of Surgery, Westmead Hospital, Corner Hawkesbury Road & Darcy Road Westmead, NSW, 2145
Country 112074 0
Australia
Phone 112074 0
+61 400219209
Fax 112074 0
Email 112074 0
henry.pleass@sydney.edu.au
Contact person for public queries
Name 112075 0
Prof Henry Pleass
Address 112075 0
Department of Surgery, Westmead Hospital, Corner Hawkesbury Road & Darcy Road Westmead, NSW, 2145
Country 112075 0
Australia
Phone 112075 0
+61 400219209
Fax 112075 0
Email 112075 0
henry.pleass@sydney.edu.au
Contact person for scientific queries
Name 112076 0
Prof Henry Pleass
Address 112076 0
Department of Surgery, Westmead Hospital, Corner Hawkesbury Road & Darcy Road Westmead, NSW, 2145
Country 112076 0
Australia
Phone 112076 0
+61 400219209
Fax 112076 0
Email 112076 0
henry.pleass@sydney.edu.au

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?
Study protocol
How or where can supporting documents be obtained?
Type [1] 12203 0
Study protocol
Citation [1] 12203 0
Link [1] 12203 0
Email [1] 12203 0
Other [1] 12203 0
Summary results
No Results