Clinical Evaluation of an HTK Solution for Liver Transplantation: A Phase 3 Randomized Pilot Clinical Trial Study.


Journal

Archives of Iranian medicine
ISSN: 1735-3947
Titre abrégé: Arch Iran Med
Pays: Iran
ID NLM: 100889644

Informations de publication

Date de publication:
01 09 2022
Historique:
received: 17 07 2021
accepted: 27 02 2022
medline: 7 8 2023
pubmed: 6 8 2023
entrez: 6 8 2023
Statut: epublish

Résumé

Organ preservation solutions are not easily accessible in Iran, similar to many resource-limited countries. We aimed to evaluate the efficacy of a locally-produced HTK solution among adult liver transplantation candidates in a pilot clinical trial study. Adult patients undergoing liver transplantation were randomly allocated into two groups. One received the HTK solution (PharMedCina Inc., Shiraz, Iran), and the second received the commercially available HTK solution (Custodiol Overall, 28 individuals entered the study, including 11 and 9 males (78.6% and 64.3%) in the Custodiol Based on the findings of this pilot study with the current sample size, no statistically significant difference was found between our locally-produced HTK solution and Custodiol

Sections du résumé

BACKGROUND
Organ preservation solutions are not easily accessible in Iran, similar to many resource-limited countries. We aimed to evaluate the efficacy of a locally-produced HTK solution among adult liver transplantation candidates in a pilot clinical trial study.
METHODS
Adult patients undergoing liver transplantation were randomly allocated into two groups. One received the HTK solution (PharMedCina Inc., Shiraz, Iran), and the second received the commercially available HTK solution (Custodiol
RESULTS
Overall, 28 individuals entered the study, including 11 and 9 males (78.6% and 64.3%) in the Custodiol
CONCLUSION
Based on the findings of this pilot study with the current sample size, no statistically significant difference was found between our locally-produced HTK solution and Custodiol

Identifiants

pubmed: 37543887
doi: 10.34172/aim.2022.97
doi:

Substances chimiques

Bretschneider cardioplegic solution 0
Organ Preservation Solutions 0
Glucose IY9XDZ35W2
Glutathione GAN16C9B8O
Insulin 0

Types de publication

Randomized Controlled Trial Clinical Trial, Phase III Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

617-623

Informations de copyright

© 2022 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Auteurs

Seyed Ali Malekhosseini (SA)

Shiraz Transplant Center, Abu Ali Sina Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.

Younes Ghasemi (Y)

Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Department of Pharmaceutical Biotechnology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.

Javad Rousta (J)

Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

Roghayyeh Aghaei (R)

Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

Sedigheh Kianpour (S)

Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

Manica Negahdaripour (M)

Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Department of Pharmaceutical Biotechnology, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.

Reza Heidari (R)

Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

Alireza Shamsaeefar (A)

Shiraz Transplant Center, Abu Ali Sina Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.

Siavash Gholami (S)

Shiraz Transplant Center, Abu Ali Sina Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.

Saman Nikeghbalian (S)

Shiraz Transplant Center, Abu Ali Sina Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.

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Classifications MeSH