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IRCT20211008052699N2 IRCT 2023-07-23 Shiraz University of Medical Sciences Investigating the effect of using the blood of a brain dead liver donor patient during liver transplantation on the liver recipient patient 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 2023-06-22 anticipated 124 Complete https://irct.ir/trial/69079 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 LIVER TRANSPLANT. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Part of the data related to the main outcome information can be shared When: Access to data starts 4 months after the publication of the article To whom: Information release will be for academic researchers only Conditions: The information can only be used for reporting in scientific congresses Where to obtain: To obtain information, send a request to Shiraz Organ Transplantation Hospital or the following email eslamina67@yahoo.com How to obtain: 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. Comments:
public alireza shamsaefar
sadra
shiraz Iran (Islamic Republic of) 8153683681 +98 71 3448 0000 eslamian67@yahoo.com Shiraz University of Medical Sciences scientific alireza shamsaefar
sadra
shiraz Iran (Islamic Republic of) 8153683681 +98 71 3448 0000 eslamian67@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 40 years Both Y83.0 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 Treatment - Drugs Treatment - Drugs 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 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 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. 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. 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. 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. 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. Shiraz University of Medical Sciences Approved 2023-03-19 Ethics committee of Shiraz University of Medical Sciences ZAND.Ave SHIRAZ Fars Iran (Islamic Republic of)