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July. 22, 2022 |
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April. 01, 2026 |
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jRCTs051220064 |
Blood cardioplegia versus cold crystalloid cardioplegia in aortic arch replacement: A prospective randomized study (Blood cardioplegia versus cold crystalloid cardioplegia in aortic arch replacement: A prospective randomized study) |
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Blood cardioplegia versus cold crystalloid cardioplegia: A prospective randomized study (Blood cardioplegia versus cold crystalloid cardioplegia: A prospective randomized study) |
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Dec. 11, 2025 |
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52 |
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Patient characteristics were similar between the groups. The median age of the entire cohort was 75 years and 86.5 % of patients had true aneurysms. One patient had a history of prior median sternotomy; however, none had a history of cardiac or great vessel surgery. The median EuroSCORE II and Japan score for the overall cohort were 2.57 % and 2.95 %, respectively. The mean preoperative LVEF was 61.4 +/- 5 % overall, with no significant difference between groups (p = 0.664). |
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Please refer to the attached sheet. |
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There was one in-hospital death in the BCP group due to brainstem infarction and pneumonia. |
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The mean postoperative LVEF was 58.3 +/- 7% in the BCP group and 59.5 +/- 7% in the CCP group. The mean difference in postoperative LVEF between the CCP and BCP groups was 1.23%. Since the lower bound of the confidence interval was above the predefined non-inferiority margin of -7%, CCP was considered non-inferior to BCP (95% CI -5.48% to 2.69%, p = 0.0041). This result was consistent in both the per-protocol and full analysis set analyses. |
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Crystalloid cardioplegia appeared to be non-inferior to cold blood cardioplegia for myocardial protection in elective aortic arch replacement, as suggested by comparable postoperative left ventricular function. |
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Mar. 31, 2026 |
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Jan. 08, 2026 |
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https://doi.org/10.1016/j.xjon.2026.101578 |
No |
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No |
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https://jrct.mhlw.go.jp/latest-detail/jRCTs051220064 |
Okada Kenji |
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Kobe University Hospital |
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7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo |
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+81-78-382-5942 |
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kokada@med.kobe-u.ac.jp |
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Hasegawa Shota |
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Kobe University Hospital |
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7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo |
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+81-78-382-5942 |
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shotatohs26@gmail.com |
Complete |
July. 22, 2022 |
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| Sept. 02, 2022 | ||
| 52 | ||
Interventional |
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randomized controlled trial |
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double blind |
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active control |
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parallel assignment |
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treatment purpose |
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1. Patients who receive aortic arch replacement |
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1. Coronary artery stenosis (> 75%) which requires an intervention |
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| 20age old over | ||
| No limit | ||
Both |
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Diseases which require aortic arch replacement |
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We administer blood cardioplegia or crystalloid cardioplegia during cardiac arrest in aortic arch replacement. |
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Left ventricular ejection fraction in thoracic cardioechography 7 days postoperatively |
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In-hospital death |
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| Kobe University Clinical Research Ethical Committee | |
| 7-5-2, Kusunoki-cho. Chuo-ku, Kobe, Hyogo, Hyogo | |
+81-78-382-6669 |
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| cerb@med.kobe-u.ac.jp | |
| Approval | |
July. 08, 2022 |
none |