UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000715 |
|---|---|
| Receipt number | R000000850 |
| Scientific Title | Japanese randomized control Study of warm Total Arch Replacement |
| Date of disclosure of the study information | 2007/05/11 |
| Last modified on | 2009/10/05 12:32:53 |
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Basic information
Public title
Japanese randomized control Study of warm Total Arch Replacement
Acronym
JSTAR-II
Scientific Title
Japanese randomized control Study of warm Total Arch Replacement
Scientific Title:Acronym
JSTAR-II
Region
| Japan |
Condition
Condition
Patients undergoing total arch replacement without any additional cardiac procedures.
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of JSTAR-II study is to evaluate the safety and the efficiency of total arch replacement under moderate hypothermia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
The primary parameter for the evaluation of the study is the total volume of transfusion.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
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.
Interventions/Control_2
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing total arch replacement without any additional cardiac procedures.
All operative procedures can be possible through median sternotomy.
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Ogino |
Organization
National Cardiovascular Center
Division name
Department of Cardiovascular Surgery
Zip code
Address
5-7-1Fujishiro-dai, Suita, Osaka, Japan
TEL
06-6833-5012
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Ogino |
Organization
National Cardiovascular Center
Division name
Department of Cardiovascular Surgery
Zip code
Address
5-7-1Fujishiro-dai, Suita, Osaka, Japan
TEL
06-6833-5012
Homepage URL
hogino@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Health,Labor,and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 05 | Month | 10 | Day |
Last modified on
| 2009 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000850
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
