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Effect of HTK solution in liver transplantation

Clinical evaluation of organ preservation HTK solution in clinical liver transplantation: a pilot randomized phase three clinical trial study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200106046029N1
Enrollment
28
Registered
2021-06-08
Start date
2019-03-21
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organ transplantation. Transplanted organ and tissue status

Interventions

Intervention 1: The intervention group received the HTK perfusion solution (Cmab Fare Zist Inc., Shiraz, Iran) according to routine transplantation protocol. Intervention 2: The control group received

Sponsors

Pharmed Cina Caspian Pouyesh Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patient undergoing liver transplantation Age above 18 years old Informed consent to enter the study

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Primary non-function of organ. Timepoint: 30 days after transplantation. Method of measurement: Blood tests and pathology biopsy.

Secondary

MeasureTime frame
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.;Acute rejection during first month. Timepoint: One month after transplantation. Method of measurement: Blood tests and pathology biopsy.;Early patient survival (3 months). Timepoint: Three months after transplantation. Method of measurement: Follow-up of patients and hospital records.;Biliary complications. Timepoint: Three months after transplantation. Method of measurement: follow-up sonography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Shamsaeefar

Shiraz University of Medical Sciences

shamsaeefar@yahoo.com+98 71 3242 5403

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026