Evaluation of early outcomes of liver transplantation from COVID-19 positive deceased donors and risk of transmission of COVID-19 in liver transplant
Design
Non-randomized non-inferiority single arm clinical trial on 10 patients requiring urgent liver transplantation
Settings and conduct
Conditions for organ harvesting: Harvest operation will be performed in the operating room of Imam Reza hospital (COVID-19 center), in accordance with all health protocols, and the harvested liver will be transferred to the transplant hospital for transplantation.
Patient follow up: postoperatively patients will be visited daily by surgeons, hepatologists and infectious disease specialists. In case of suspicion for COVID-19, PCR and lung HRCT will be performed. For all patients, two PCR tests will be done respectively in day 7 and 14 postoperatively.
Participants/Inclusion and exclusion criteria
Recipients: patients with acute liver failure requiring urgent liver transplantation without any clinical manifestation of COVID-19 and No lung involvement in HRCT and negative PCR test.
Donors: Deceased due to non respiratory failure / positive COVID-19 PCR test or lung involvement in HRCT
Intervention groups
Harvesting liver from COVID-19 positive deceased donors and transplant to patients requiring urgent liver transplantation
Main outcome variables
Early outcomes of liver transplantation; transmission of COVID-19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200928048867N1
Registration date:2020-10-22, 1399/08/01
Registration timing:registered_while_recruiting
Last update:2020-10-22, 1399/08/01
Update count:0
Registration date
2020-10-22, 1399/08/01
Registrant information
Name
Sara Saeidi Shahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3845 8671
Email address
saeidis971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of short term outcomes of liver transplantation from COVID-19 positive deceased donors
Public title
Evaluation of short term outcomes of liver transplantation from COVID-19 positive deceased donors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Recipients with acute liver failue and MELD score> 20 requiring urgent liver transplant
Recipients should have Negetive PCR test/ NO COVID-19 signs and symptoms/ NO lung involvement in HRCT
Deceased donors with positive PCR tests or COVID-19 lung involvement in HRCT
Exclusion criteria:
Recipients with clinical presentation of COVID-19 OR positive PCR test OR lung involvement in HRCT
Deceased donors due to respiratory failure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
General Surgery Department, Imam Reza Hospital, Ibnesina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.MUMS.REC.1399.442
Health conditions studied
1
Description of health condition studied
Acute liver failure
ICD-10 code
K74
ICD-10 code description
Fibrosis and cirrhosis of liver
Primary outcomes
1
Description
Description of early outcomes of liver transplant from COVID-19 positive deceased donors
Timepoint
30 days within operation
Method of measurement
Clinical assessments/ liver functional tests
2
Description
Evaluation of transmission of COVID-19
Timepoint
24 hours, day 7 and 14 postoperatively
Method of measurement
Clinical manifestations, PCR test, lung HRCT
Secondary outcomes
1
Description
Long term outcomes of liver transplant from COVID-19 positive deceased donors