Protocol summary
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Study aim
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Evaluating the efficacy and safety of a locally produced organ preservation and perfusion solution similar to the imported product called Custodial HTK solution in clinical liver transplantation
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Design
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This is a pilot, randomized, single-blind, phase III parallel design clinical trial study comparing two organ perfusion solutions among 28 candidates for liver transplantation. The randomization sequence for the two comparison groups was generated with an online program available at https://www.sealedenvelope.com/simple-randomiser/v1/lists.
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Settings and conduct
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The study was conducted in the Shiraz Transplant Center located in Abu Ali Sina Hospital, Shiraz, Iran. Candidates for liver transplantation were categorized in two groups. The intervention group received a locally produced organ preservation and perfusion solution similar to the imported product Custodial HTK solution. The control group received the Custodial HTK solution. Patients were blinded to the perfusion solution patients have received.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patient undergoing liver transplantation; age above 18 years old; informed consent to enter the study.
Exclusion criteria: those with organ donations from outside of the province; pregnant patients or those who are lactating; those with donations after cardiac death (DCD); those who are undergoing re-transplantations and those with machine perfusion.
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Intervention groups
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The intervention group received a locally produced organ preservation and perfusion solution similar to the imported product Custodial HTK solution. The control group received the Custodial HTK solution.
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Main outcome variables
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Primary non-function of liver; changes in AST and ALT on the first day after transplantation up to the day of discharge; acute rejection during first month; early patient survival (3 months); biliary complications
General information
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Reason for update
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The block size was a typo (an error in data entry within the website).
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200106046029N1
Registration date:
2021-06-08, 1400/03/18
Registration timing:
retrospective
Last update:
2021-10-06, 1400/07/14
Update count:
1
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Registration date
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2021-06-08, 1400/03/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-03-21, 1398/01/01
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Expected recruitment end date
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2020-03-20, 1399/01/01
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Actual recruitment start date
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2019-04-26, 1398/02/06
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Actual recruitment end date
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2020-08-18, 1399/05/28
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Trial completion date
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2021-01-25, 1399/11/06
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Scientific title
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Clinical evaluation of organ preservation HTK solution in clinical liver transplantation: a pilot randomized phase three clinical trial study
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Public title
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Effect of HTK solution in liver transplantation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patient undergoing liver transplantation
Age above 18 years old
Informed consent to enter the study
Exclusion criteria:
Those with organ donations from outside of the province
Pregnant patients or those who are lactating
Those with donations after cardiac death (DCD)
Those who are undergoing re-transplantations
Those with machine perfusion
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
28
Actual sample size reached:
28
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The eligible study participants (n=28) were randomized into two study arms (1:1) using the permuted block randomization with a fixed block size of 4. The randomization sequence will be generated with an online program available at https://www.sealedenvelope.com/simple-randomiser/v1/lists.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The generated random sequence were inserted in opaque envelops enumerated in sequence from 01 to 28, each of which will be used for consecutive study participants.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-08-14, 1398/05/23
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Ethics committee reference number
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IR.SUMS.REC.1398.626
Health conditions studied
1
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Description of health condition studied
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Organ transplantation
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ICD-10 code
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Z94
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ICD-10 code description
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Transplanted organ and tissue status
Primary outcomes
1
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Description
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Primary non-function of organ
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Timepoint
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30 days after transplantation
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Method of measurement
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Blood tests and pathology biopsy
Secondary outcomes
1
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Description
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Changes in AST and ALT on the first day after transplantation up to discharge
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Timepoint
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One day after transplantation up to discharge
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Method of measurement
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Blood test
2
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Description
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Acute rejection during first month
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Timepoint
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One month after transplantation
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Method of measurement
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Blood tests and pathology biopsy
3
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Description
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Early patient survival (3 months)
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Timepoint
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Three months after transplantation
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Method of measurement
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Follow-up of patients and hospital records
4
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Description
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Biliary complications
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Timepoint
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Three months after transplantation
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Method of measurement
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follow-up sonography
Intervention groups
1
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Description
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The intervention group received the HTK perfusion solution (Cmab Fare Zist Inc., Shiraz, Iran) according to routine transplantation protocol.
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Category
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Treatment - Other
2
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Description
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The control group received the Custadiol® HTK solution according to routine transplantation protocol.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Pharmed Cina Caspian Pouyesh Company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available