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Trial registered on ANZCTR


Registration number
ACTRN12621001135808p
Ethics application status
Submitted, not yet approved
Date submitted
6/07/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
iiPJ (ischemic injury protective jacket) Feasibility Study
Scientific title
The effect of intraoperative thermal kidney insulation on current kidney transplantation surgical practices: a pilot feasibility study.
Secondary ID [1] 304693 0
None
Universal Trial Number (UTN)
Trial acronym
FSIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed graft function 322677 0
graft failure 322678 0
Condition category
Condition code
Surgery 320292 320292 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing kidney transplantation from deceased or living donors including multiorgan transplantation (i.e. simultaneous pancreas and kidney transplants) shall be considered for enrolment. Patients must be aged 18 years and above. First and second transplant patients shall be accepted. The intervention is non-pharmacological. Donor kidneys will undergo preservation by cold storage followed by anatomosis to the recipient temporarily placed within the iiPJ (ischaemic injury protective jacket). The kidney transplant shall be otherwise performed using standard techniques. Suitable kidneys will be placed in iiPJ after backtable preparation and left in cold storage (CS) until the recipient is ready for implantation. A non-invasive temperature of the exposed kidney at the hilum will be taken using a laser thermometer, directly prior to commencement of vascular anastomoses. When the recipient procedure has progressed to the reimplantation stage the iiPJ™ with the donor kidney insitu will be taken out of the ice and CS into the operative field within the patient for anastomosis. Once renal artery and vein are anastomosed, the iiPJ™ will be rapidly removed and discarded, the temperature of the kidney recorded using a non-invasive laser thermometer directly prior to reperfusion. The iiPJ is to be used by the principal investigator and transplant team, all of whom have been trained in the use of the iiPJ.

The iiPJ is a silicone kidney jacket that the kidney is placed into and secured via securing tabs to ensure the kidney does not fall out of the jacket. There is an opening at the top of the jacket through which the important vasculature is accessible. The iiPJ is designed to thermally insulate the kidney from the outer environment of the open cavity of the recipient in order to slow down the thermal increase in the kidney's temperature over time.

The iiPJ is to be for the duration of the transplantation procedure from when the kidney is removed from ice till when anastomoses occurs of the important vasculature. This time period is approximately 30-45 minutes but could extend if surgical complications arise and the transplant takes longer than average (30 minutes at Westmead Hospital, 41 minutes global average).

To monitor adherence to the intervention, surgical records shall be taken of:
- usage of iiPJ through transplant (iiPJ used or not used)
- time at which iiPJ is placed on kidney
- time at which iiPJ is removed
- further comments by surgical staff
Intervention code [1] 321069 0
Treatment: Devices
Comparator / control treatment
No control group, as this is a feasibility study for the use of the iiPJ within a surgical setting using standard surgical techniques. This shall include 10-20 kidney transplants to include the use of the iiPJ. However, the iiPJ protected kidney transplants shall be compared with kidney transplants performed without the use of the iiPJ via historical data sourced from the renal transplant unit at Westmead Hospital and ANZDATA for the preceding 5 years (01/01/2016-31/12-2020)
Control group
Historical

Outcomes
Primary outcome [1] 328145 0
Composite subjective ease of use score as measured by a questionnaire. The questionnaire shall be study-specific.
Timepoint [1] 328145 0
Duration of transplantation procedure from the removal of the kidney from ice on the backtable to the successful anastomosis of the kidney within the recipient.
Secondary outcome [1] 397822 0
Delayed Graft Function defined as the need for dialysis in the first 7 days post-transplantation recorded prospectively via electronic medical records/clinical review as necessary. The decision for post-transplant dialysis is made by the transplant physician on call.
Timepoint [1] 397822 0
First 7 days post-transplantation
Secondary outcome [2] 397823 0
Creatinine reduction ratio assessed via serum creatinine blood samples collected routinely as part of transplantation. No additional post-operative tests are required for this study.
Timepoint [2] 397823 0
1, 3, 6, and 12 months post-transplantation.
Secondary outcome [3] 397824 0
Length of hospital stay post-transplantation via patient medical records.
Timepoint [3] 397824 0
At time of hospital discharge, or death is this occurs.
Secondary outcome [4] 397825 0
Biopsy-proven acute rejection rates
Timepoint [4] 397825 0
1, 3, 6, and 12 months post-transplantation.
Secondary outcome [5] 397826 0
Patient survival
Timepoint [5] 397826 0
For surviving patients, overall survival will be censored on the date the patient was last known to be alive as assessed at 3 years post treatment commencement
Secondary outcome [6] 397827 0
Allograft Survival via patient medical records.
Timepoint [6] 397827 0
Time from transplant to graft loss or return to dialysis dependence for a maximum of five years.
Secondary outcome [7] 397828 0
Perioperative complications via surgical records.
Timepoint [7] 397828 0
Duration of transplantation procedure.
Secondary outcome [8] 397829 0
SWIT (second warm ischaemic time) via surgical records.
Timepoint [8] 397829 0
Time from when the kidney is taken out of cold storage until the kidney is reperfused in the recipient.
Secondary outcome [9] 398678 0
Serum creatinine
Timepoint [9] 398678 0
1, 3, 6, and 12 months post-transplantation.
Secondary outcome [10] 398679 0
Estimated Glomerular Filtration Rate via routine blood sampling, not specific to this trial.
Timepoint [10] 398679 0
1, 3, 6, and 12 months post-transplantation.

Eligibility
Key inclusion criteria
Patients undergoing kidney transplantation from deceased or living donors including multiorgan transplantation (i.e. simultaneous pancreas and kidney transplants).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient deemed unfit for the usage of iiPJ during the transplantation procedure by the principal investigator and transplant team. No paediatric recipient will be included in this trial. Patients who have either mental health or communication issues, such that they cannot consent or understand the trial will also be excluded. However, both of these are usually a contraindication to transplantation, if they are unable to comply with standard post-transplant care. Furthermore, patients undergoing their 3rd or more transplant or multi-organ transplantation will also be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This is primarily a feasibility study to ensure safety with this technology, not previously used within Australia. Provided the small series shows no added complications to the recipients, a larger prospective RCT will be required to confirm statistical benefits in terms of incidence of DGF, allograft survival and eGFR at 1 year. Outcomes that will be compared will include DGF rate, and eGFR, graft, and patient survivals at 1, 6, and 12 months post-transplantation.

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] 19914 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 34614 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 309061 0
Government body
Name [1] 309061 0
Western Sydney Local Health District
Address [1] 309061 0
Institute Road,
Westmead NSW 2145
Country [1] 309061 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Institute Road,
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 310018 0
None
Name [1] 310018 0
Address [1] 310018 0
Country [1] 310018 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308937 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 308937 0
Westmead Hospital
Westmead
Darcy Rd NSW 2145
Ethics committee country [1] 308937 0
Australia
Date submitted for ethics approval [1] 308937 0
28/07/2021
Approval date [1] 308937 0
Ethics approval number [1] 308937 0
Ethics committee name [2] 308938 0
Bellberry Limited
Ethics committee address [2] 308938 0
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [2] 308938 0
Australia
Date submitted for ethics approval [2] 308938 0
28/10/2021
Approval date [2] 308938 0
Ethics approval number [2] 308938 0

Summary
Brief summary
This is a feasilibility study to determine if use of iiPJ™ (Ischaemic Injury Protective Jacket) during renal transplantation is feasible and implementable in the Australian kidney transplant setting. In addition, it shall also assess whether the iiPJ™ improves transplantation outcomes from ‘marginal’ or higher risk grafts currently used for transplantation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112398 0
Prof Henry Pleass
Address 112398 0
Dept of Surgery
Westmead Hospital
Darcy Rd
Westmead, NSW 2145
Country 112398 0
Australia
Phone 112398 0
+61 2 88906821
Fax 112398 0
Email 112398 0
henry.pleass@sydney.edu.au
Contact person for public queries
Name 112399 0
Prof Henry Pleass
Address 112399 0
Dept of Surgery
Westmead Hospital
Darcy Rd
Westmead, NSW 2145
Country 112399 0
Australia
Phone 112399 0
+61 2 88906821
Fax 112399 0
Email 112399 0
henry.pleass@sydney.edu.au
Contact person for scientific queries
Name 112400 0
Prof Henry Pleass
Address 112400 0
Dept of Surgery
Westmead Hospital
Darcy Rd
Westmead, NSW 2145
Country 112400 0
Australia
Phone 112400 0
+61 2 88906821
Fax 112400 0
Email 112400 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?
No other documents available
Summary results
No Results