Japanese randomized control Study of warm Total Arch Replacement

UMIN ID: UMIN000000715

Registered date:11/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients undergoing total arch replacement without any additional cardiac procedures.
• Date of first enrollment: 2007/05/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 2 deg C, and the perfusion pressure of SCP should be between 30 and 50mmHg.

Outcome(s)

• Primary Outcome: The primary parameter for the evaluation of the study is the total volume of transfusion.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: National Cardiovascular Center
• Source(s) of Monetary Support: Japanese Ministry of Health,Labor,and Welfare