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Japanese

July. 22, 2022

April. 01, 2026

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)

Blood cardioplegia versus cold crystalloid cardioplegia: A prospective randomized study (Blood cardioplegia versus cold crystalloid cardioplegia: A prospective randomized study)

Dec. 11, 2025

52

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).

Please refer to the attached sheet.

There was one in-hospital death in the BCP group due to brainstem infarction and pneumonia.

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.

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.

Mar. 31, 2026

Jan. 08, 2026

https://doi.org/10.1016/j.xjon.2026.101578

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs051220064

Okada Kenji

Kobe University Hospital

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo

+81-78-382-5942

kokada@med.kobe-u.ac.jp

Hasegawa Shota

Kobe University Hospital

7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo

+81-78-382-5942

shotatohs26@gmail.com

Complete

July. 22, 2022

Sept. 02, 2022
52

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

1. Patients who receive aortic arch replacement
2. More than 20 years old
3. Patients who give written informed consent

1. Coronary artery stenosis (> 75%) which requires an intervention
2. Preoperative left ventricular systolic dysfunction (EF < 50%)
3. Emergent cases
4. Patients deemed inappropriate by the investigators

20age old over
No limit

Both

Diseases which require aortic arch replacement

We administer blood cardioplegia or crystalloid cardioplegia during cardiac arrest in aortic arch replacement.

Left ventricular ejection fraction in thoracic cardioechography 7 days postoperatively

In-hospital death
Overall survival
Incidence of low output syndrome
Incidence of postoperative myocardial infarction
Dosage of cardioplegia
CK / CK-MB release
Incidence of left ventricular diastolic dysfunction
Incidence of right ventricular systolic dysfunction
Incidence of ventricular arrhythmia after return to spontaneous rhythm
Incidence of new-onset atrial fibrillation 48 hours postoperatively
Requirement for implantation of permanent pacemaker
Incidence of cerebral stroke
Incidence of renal dysfunction
Duration of ventilatory support
Amount of intraoperative bleeding
Amount of intraoperative and postoperative transfusion
Re-exploration for bleeding
Occurence of diseases, etc.

Kobe University Clinical Research Ethical Committee
7-5-2, Kusunoki-cho. Chuo-ku, Kobe, Hyogo, Hyogo

+81-78-382-6669

cerb@med.kobe-u.ac.jp
Approval

July. 08, 2022

none

History of Changes

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7 April. 01, 2026 (this page) Changes
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1 July. 22, 2022 Detail