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Single-center, unblinded, randomized comparison study between new cardiopulmonary bypass circuit "Oxia N" and existing circuit.

Single-center, unblinded, randomized comparison study between new cardiopulmonary bypass circuit "Oxia N" and existing circuit. - Single-center, unblinded, randomized comparison study between new cardiopulmonary bypass circuit "Oxia N" and existing circuit.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035888
Enrollment
20
Registered
2019-02-21
Start date
2018-01-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aortic arch aneurysm

Interventions

Intervention group: Pre-connect circuit manufactured by JMS Inc. is used during aortic arch surgery (artificial lung, centrifugal pump, main circuit with MPC coating) Control group: Pre-connect circui

Sponsors

Keio University School of Medicine, Department of Cardiovscular Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients for aortic arch surgery, limited to initial surgery, who weigh 50 to 80 kg, only when it is judged that the blood flow rate during surgery is not more than the maximum flow rate (7 L / min) of each product.

Exclusion criteria

Exclusion criteria: Patients who are judged that clinical evaluation can not be performed properly, depending on the judgment of the attending surgeon. (renal dysfunction, liver dysfunction, diabetes, anticoagulation disorder, malignant tumor, autoimmune disease etc.)

Design outcomes

Primary

MeasureTime frame
Protein in blood, inflammatory marker, coagulation marker are measured at the following 6 points. That is, before the start of extracorporeal circulation, immediately after the start of extracorporeal circulation, 60 minutes after extracorporeal circulation, at the end of extracorporeal circulation, 120 minutes after extracorporeal circulation, after the first sickness day.

Secondary

MeasureTime frame
SEM observation Regarding products such as artificial lung, centrifugal pump etc. after extracorporeal circulation

Countries

Japan

Contacts

Public ContactTsutomu Ito

Keio University School of Medicine Department of Cardiovscular Surgery

tsutomu110.1965@gmail.com03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026