Study of the safety of Organ pocket during operation of kidney transplant recipients

JRCT ID: jRCTs062210034

Registered date:09/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Kidney Transplantation
• Date of first enrollment: 20/10/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): The Kidney graft is put into the Thermal Barrier Bag (TBB) at ex vivo cooling perfusion and kept it during vascular anastomosis. After vascular anastomosis is complete, TBB is carefully removed from kidney graft and subsequent surgical procedures are continued.

Outcome(s)

Primary Outcome

1) Adverse event
2) Device failure
3) Laboratory value
4) Vital sign
5) Respiratory and circulatory dynamics during vascular anastomosis of recipient operation

Secondary Outcome

1) Organ surface temperature during anastomosis in kidney transplant recipient surgery
2) Anastomosis time in kidney transplant recipient surgery

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

1) Pre-kidney transplant patients aged 20 to 70 years old at the time of obtaining written consent.
2) Written informed consent.

Exclude criteria

1) Hypersensitivity to resin.
2) Any other patients regarded unsuitable by the principal investigator or sub-investigators

Related Information

• Primary Sponsor: Ohdan Hideki
• Source(s) of Monetary Support: SCREEN holdings Co,.Ltd.