Skip to content

Japanese randomized control Study of warm Total Arch Replacement

Japanese randomized control Study of warm Total Arch Replacement - JSTAR-II

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000715
Enrollment
100
Registered
2007-05-11
Start date
2007-05-01
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

Patients undergoing total arch replacement without any additional cardiac procedures.

Interventions

Group of 28 deg C : Temperature at bladder should be 28 plus minus 2 deg C, and the perfusion pressure of SCP should be over 50mmHg. Group of 20 deg C : Temperature at bladder should be 20 plus minus

Sponsors

National Cardiovascular Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing total arch replacement without any additional cardiac procedures. All operative procedures can be possible through median sternotomy.

Exclusion criteria

Exclusion criteria: 1) Emergency cases 2) Extended aneurysms, i.e., existence of concomitant root, descending, thoracoabdominal, abdominl aneurysms. 3) Patients with severe atheromatous lesion. 4) Atypical aortic diseases, i.e., Takayasu disease, Behcet disease, Marfan syndrome, Ehlers-Danlos syndrome. 5) Severe grade of arteriosclerosis obliterans. 6) Re-sternotomy cases 7) Abnormality of neurological, cardiac, respiratory, hepatic, renal, hematological functions. 8) Infections 9) Cancer-bearing patients. 10) Mental diseases, including dementia. 11) Other improper patients judged by physician-in-charge

Design outcomes

Primary

MeasureTime frame
The primary parameter for the evaluation of the study is the total volume of transfusion.

Secondary

MeasureTime frame
The other parameters for the evaluation of the study are operative death, neurological complications, cardiac complications, respiratory complications, renal complications, amount of bleeding, and infectious complications.

Countries

Japan

Contacts

Public ContactHitoshi Ogino

National Cardiovascular Center Department of Cardiovascular Surgery

hogino@hsp.ncvc.go.jp06-6833-5012

Outcome results

None listed

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