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Study aim
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Comparison of the effect of using cardioplegic substances through the descending and ascending aorta in the simultaneous removal of the heart and liver on the effectiveness of the transplant and the amount of cardioplegic substance used.
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Design
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The potential 54 organ donors are dividing in two groups consisting of control and main groups with randomization by sealed envelope. This study is a double-blind clinical trial and only the operating surgeon of the study has the complete information of each patient. The rest of the medical team performing before and after surgery observations are not aware of patients’ study group.
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Settings and conduct
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This is a phase IIrandomized controlled clinical trial, aiming to compare the use of the cardioplegic material through the descending and ascending aorta in the simultaneous removal of the heart and liver in organ donation. Only the operating surgeon of the study has the complete information of each patient.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Eligible for organ donation and have consent and aware of the donation
Exclusion criteria: Liver cirrhosis, heart failure, and prior heart surgery
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Intervention groups
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In the control group, we using the classic strategy of cardioplegic solution infusion in the root of the aorta. In the main group, we use the new method that consists of sternotomy, complete isolation of aortic arch arteries, the clamp of ascending aorta, and injection of solution to descending aorta.
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Main outcome variables
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The cardiac ejection fraction, right after surgery, 2 weeks, 1month, 3 months, 6 months, and 1 year after the operation
The volume of the cardioplegic solution used in the surgeries
The duration of the surgeries