None listed
Conditions
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.
Interventions
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 b
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.
Sponsors
Westmead Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Exclusion criteria is any patients with previous adverse reactions or anaphylaxis to Methylene Blue and those who are being re-transplanted.
Outcome results
None listed