CompletedPhase 1ACTRN12621000985886

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


Sponsor

Westmead Hospital

Enrollment

50 participants

Start Date

Aug 1, 2022

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

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

Interested in this trial?

Get notified about updates and connect with the research team.

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-li

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.


Locations(1)

Westmead Hospital - Westmead

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12621000985886


Related Trials