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Investigating the effect of using the blood of a brain dead liver donor patient during liver transplantation on a liver recipient patient at Abu Ali Sina organ transplant center in 2023

Protocol summary

Study aim
Determining and comparing the amount of bleeding during and after liver transplant , the amount of blood injected during liver transplant surgery and after surgery, the rate of hepatic artery thrombosis after liver transplant, the rate of portal vein thrombosis, the rate of mortality during liver transplant surgery and after surgery., the rate of a primary dysfunction of the transplanted liver in each group and between the two groups
Design
The clinical trial, two parallel groups, phase 3, use of 4 block method with randomization software, double-blind, sample size 124
Settings and conduct
Shiraz, Iran double-blind. The person who receives the organ and the person who collects the information during and after the operation does not know the type of injected product.
Participants/Inclusion and exclusion criteria
Stability in vital signs Not receiving a high dose of an inotrope, Hemoglobulin level above 11, Age 18 to 40 years, Having the same blood group between the donor and the RH receptor Matching crossmatch, Transplantation from a brain-dead donor, Liver transplant for the first time ; blood transfusions other than blood collected from brain-dead patients Insufficient blood collected Bleeding more than 2000 cc in transplant surgery
Intervention groups
intervention group, patients whose blood will inject into them during and after liver transplantation from blood taken from a brain-dead patient.control group, patients whose blood was injected during and after liver transplantation from a random donor
Main outcome variables
1. Bleeding during and after liver TX in blood recipient group from brain death 2. Bleeding rate during and after liver TX in blood recipient group from random donor 3.amount of blood injected during the liver transplant in blood recipient group from brain death 4:amount of blood injected during the liver transplant in random donor blood recipient group

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211008052699N2
Registration date: 2023-07-23, 1402/05/01
Registration timing: registered_while_recruiting

Last update: 2023-07-23, 1402/05/01
Update count: 0
Registration date
2023-07-23, 1402/05/01
Registrant information
Name
Mohammad Eslamian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
mr.esl67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using the blood of a brain dead liver donor patient during liver transplantation on a liver recipient patient at Abu Ali Sina organ transplant center in 2023
Public title
Investigating the effect of using the blood of a brain dead liver donor patient during liver transplantation on the liver recipient patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stability in vital signs (heart rate less than 100 R/M, systolic pressure more than 100 mmHg). Hemoglobin level above 11 Age 18 to 40 years having blood group and RH between the donor and the recipient The same immunological conditions between donor and recipient in terms of cytomegaloviruses Matching based on sender and receiver cross match Transplantation from a brain dead donor Whole liver transplant Stability of vital signs at the time of liver transplant surgery Failure to receive inotrope before the transplant procedure No grade 3 or 4 encephalopathy before transplantation Age between 18 and 40 years Absence of evidence of portal vein thrombosis in preoperative examinations Liver transplant for the first time Not having a history of hepatic vein thrombosis (Bodekiari syndrome) or other diseases with high blood coagulation potential.
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups using computer randomization. This randomization of patients will be done by an independent computer programmer using the www.randomization.com database.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind. The person who receives the organ and the person who collects the information during and after the operation does not know the type of injected product. The information during the operation is based on list number one and the information after the operation is based on the checklist. Number 2 is recorded by a trained anesthesiologist.
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
ZAND.Ave
City
SHIRAZ
Province
Fars
Postal code
8153683681
Approval date
2023-03-19, 1401/12/28
Ethics committee reference number
IR.SUMS.REC.1401.543

Health conditions studied

1

Description of health condition studied
LIVER TRANSPLANT
ICD-10 code
Y83.0
ICD-10 code description
Surgical operation with transplant of whole organ as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Primary outcomes

1

Description
Bleeding rate during liver transplant surgery and after surgery (first 24 hours)
Timepoint
During the operation and up to 24 hours after the operation
Method of measurement
Questionnaire

2

Description
The amount of blood injected during the liver transplant operation and after the operation (first 24 hours)
Timepoint
During the operation and up to 24 hours after the operation
Method of measurement
Questionnaire

3

Description
The rate of hepatic artery thrombosis during liver transplantation and after the operation (the first two weeks after transplantation)
Timepoint
During the transplant operation up to two weeks after the transplant
Method of measurement
Doppler ultrasound, CT abdominal angiography

4

Description
Mortality rate during liver transplant surgery and after surgery (first 30 days after transplant)
Timepoint
The first 30 days after liver transplantation
Method of measurement
questionnaire

5

Description
The degree of initial dysfunction of the transplanted liver (during the first week). Number of days of hospitalization in ICU after transplantation
Timepoint
The first week after transplantation
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: blood transfusion from a brain dead donor to a patient undergoing liver transplantation.The outcome of patients after transplantation is checked and recorded based on the checklist
Category
Treatment - Drugs

2

Description
Control group: Control group: blood transfusion from a non-brain-dead donor (from the blood bank) to a patient undergoing liver transplantation. In this group, based on the need for blood transfusion during the operation, blood is provided and injected from the blood bank. The outcome of the patients after transplantation is based on The checklist is checked and recorded
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
abu ali sina transplant center
Full name of responsible person
alireza shamsaefar
Street address
sadra.st
City
shiraz
Province
Fars
Postal code
8153683681
Phone
+98 71 3448 0000
Email
eslamian67@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
alireza shamsaefar
Street address
sadra
City
shiraz
Province
Fars
Postal code
8153683681
Phone
+98 71 3448 0000
Email
eslamian67@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
alireza shamsaefar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
sadra
City
shiraz
Province
Fars
Postal code
8153683681
Phone
+98 71 3448 0000
Email
eslamian67@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
alireza shamsaefar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
sadra
City
shiraz
Province
Fars
Postal code
8153683681
Phone
+98 71 3448 0000
Email
eslamian67@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
alireza shamsaefar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
sadra
City
shiraz
Province
Fars
Postal code
8153683681
Phone
+98 71 3448 0000
Email
eslamina67@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data related to the main outcome information can be shared
When the data will become available and for how long
Access to data starts 4 months after the publication of the article
To whom data/document is available
Information release will be for academic researchers only
Under which criteria data/document could be used
The information can only be used for reporting in scientific congresses
From where data/document is obtainable
To obtain information, send a request to Shiraz Organ Transplantation Hospital or the following email eslamina67@yahoo.com
What processes are involved for a request to access data/document
After the request is sent by email, it will be reviewed by the research committee of the center, and if the conditions are met, it will be sent within 2 months.
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