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
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention 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.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200106046029N1
Registration date:2021-06-08, 1400/03/18
Registration timing:retrospective
Last update:2021-06-08, 1400/03/18
Update count:1
Registration date
2021-06-08, 1400/03/18
Registrant information
Name
Manica Negahdaripour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 5403
Email address
negahdaripour@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2019-04-26, 1398/02/06
Actual recruitment end date
2020-08-18, 1399/05/28
Trial completion date
2021-01-25, 1399/11/06
Scientific title
Clinical evaluation of organ preservation HTK solution in clinical liver transplantation: a pilot randomized phase three clinical trial study
Public title
Effect of HTK solution in liver transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
28
Actual sample size reached:
28
Randomization (investigator's opinion)
Randomized
Randomization description
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 2. The randomization sequence will be generated with an online program available at https://www.sealedenvelope.com/simple-randomiser/v1/lists.
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Administration Building of Shiraz University of Medical Sciences - Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2019-08-14, 1398/05/23
Ethics committee reference number
IR.SUMS.REC.1398.626
Health conditions studied
1
Description of health condition studied
Organ transplantation
ICD-10 code
Z94
ICD-10 code description
Transplanted organ and tissue status
Primary outcomes
1
Description
Primary non-function of organ
Timepoint
30 days after transplantation
Method of measurement
Blood tests and pathology biopsy
Secondary outcomes
1
Description
Changes in AST and ALT on the first day after transplantation up to discharge
Timepoint
One day after transplantation up to discharge
Method of measurement
Blood test
2
Description
Acute rejection during first month
Timepoint
One month after transplantation
Method of measurement
Blood tests and pathology biopsy
3
Description
Early patient survival (3 months)
Timepoint
Three months after transplantation
Method of measurement
Follow-up of patients and hospital records
4
Description
Biliary complications
Timepoint
Three months after transplantation
Method of measurement
follow-up sonography
Intervention groups
1
Description
The intervention group received the HTK perfusion solution (Cmab Fare Zist Inc., Shiraz, Iran) according to routine transplantation protocol.
Category
Treatment - Other
2
Description
The control group received the Custadiol® HTK solution according to routine transplantation protocol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu-Ali-Sina Center for Medicine and Organ Transplant
Full name of responsible person
Saman Nikeghbalian
Street address
Abu-Ali-Sina Center for Medicine and Organ Transplant- Phase 2- Sadra
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 5403
Fax
+98 71 1640 3061
Email
monica.negahdaripour@yahoo.com
Web page address
http://www.shiraztransplant.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmed Cina Caspian Pouyesh Company
Full name of responsible person
---
Street address
Biotechnology Incubator-------
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 5257
Fax
+98 71 3242 5257
Email
aaa@gmail.com
Web page address
http://www.PharMedCina.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmed Cina Caspian Pouyesh Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Shamsaeefar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hepato Pancreato Biliary Surgery and Abdominal Organ Transplantation Department of Surgery, School of Medicine
Street address
Abu Ali Sina for Medicine & Organ Transplant Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 5403
Email
shamsaeefar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Shamsaeefar
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Hepato Pancreato Biliary Surgery and Abdominal Organ Transplantation Department of Surgery, School of Medicine
Street address
Abu Ali Sina for Medicine & Organ Transplant
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 5403
Fax
Email
shamsaeefar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Manica Negahdaripour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shiraz School of Pharmacy- Karafarin St
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 5403
Fax
+98 71 3242 5403
Email
monica.negahdaripour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available