Safety and Feasibility Assessment of Using Hemoperfusion with HA380 Filter to Improve Heart and Liver Transplant Outcomes
Design
A single arm phase I trial with a sample size of 5, based on 5 patients in the intervention group (will undergo hemoperfusion before organ procurement)
Settings and conduct
This single arm phase I trial with a sample size of 5 will conduct in Hazrat Rasool Akram Medical Research Training Center on 5 heart donors. This organ donors will undergo hemoperfusion, through the HA380 cartridge, before procure the heart for transplantation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: eligible for organ donation, have consent and aware of donation
Exclusion criteria: liver cirrhosis, heart failure, prior heart surgery
Intervention groups
Intervention group: This group includes organ donors who will undergo hemoperfusion through the HA380 cartridge. First, sternotomy, complete separation of the aortic arch arteries and simultaneous ligation of the azygos and superior vena cava are performed, and after the preparation of the abdomen, abdominal aortic cannulation of the patients will be subjected to hemoperfusion through the HA380 cartridge. Finally, we procure the heart for donation.
Main outcome variables
Survival of heart recipient six months and one year after transplantation.
Ejection fraction of heart recipient six months and one year after transplantation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220919055992N2
Registration date:2023-06-18, 1402/03/28
Registration timing:retrospective
Last update:2023-06-18, 1402/03/28
Update count:0
Registration date
2023-06-18, 1402/03/28
Registrant information
Name
Mohammadhosein Akhlaghpasand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 844 5400
Email address
akhlaghpasandm@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-31, 1401/08/09
Expected recruitment end date
2022-11-05, 1401/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and Feasibility Study of Using Hemoperfusion with HA380 Filter to Improve Heart and Liver Transplant Outcomes: Phase I Clinical Trial
Public title
Using Hemoperfusion with HA380 Filter to Improve Heart and Liver Transplant Outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
eligible for organ donation
have consent and aware of donation
Exclusion criteria:
liver cirrhosis
heart failure
prior heart surgery
Age
From 18 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
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 in Biomedical Researches of the Iran university of medical sciences of Sciences
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences, Central Headquarters Building, Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1988834567
Approval date
2023-06-12, 1402/03/22
Ethics committee reference number
IR.IUMS.REC.1402.208
Health conditions studied
1
Description of health condition studied
Donors of organs and tissues
ICD-10 code
Z52
ICD-10 code description
Donors of organs and tissues
Primary outcomes
1
Description
The cardiac ejection fraction
Timepoint
six months and one year after transplantation.
Method of measurement
month
2
Description
Survival of heart recipient.
Timepoint
six months and one year after transplantation.
Method of measurement
percent
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group includes organ donors who will undergo hemoperfusion through the HA380 cartridge. First, sternotomy, complete separation of the aortic arch arteries and simultaneous ligation of the azygos and superior vena cava are performed, and after the preparation of the abdomen, abdominal aortic cannulation of the patients will be subjected to hemoperfusion through the HA380 cartridge. Finally, we procure the heart for donation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Akram Medical Research Training Center