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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000715
Receipt No. 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

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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
Email

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
Email hogino@hsp.ncvc.go.jp

Sponsor
Institute National Cardiovascular Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000850

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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