UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000435 |
|---|---|
| Receipt number | R000000529 |
| Scientific Title | Prospective comparative study of neurocognitive function after total arch replacement: intermittent pressure augmented or conventional retrograde cerebral perfusion |
| Date of disclosure of the study information | 2006/06/23 |
| Last modified on | 2006/06/23 13:36:26 |
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Basic information
Public title
Prospective comparative study of neurocognitive function after total arch replacement: intermittent pressure augmented or conventional retrograde cerebral perfusion
Acronym
Comparative study of neurocognitive function: intermittent pressure augmented or conventional retrograde cerebral perfusion
Scientific Title
Prospective comparative study of neurocognitive function after total arch replacement: intermittent pressure augmented or conventional retrograde cerebral perfusion
Scientific Title:Acronym
Comparative study of neurocognitive function: intermittent pressure augmented or conventional retrograde cerebral perfusion
Region
| Japan |
Condition
Condition
Patients undergoing total arch replacement
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the neurocognitive results of the two different brain protection, intermittent pressure augmented and conventional retrograde cerebral perfusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Neurocognitive function assessed by the revised Wechsler Adult Intelligence Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intermittent pressure augmented retrograde cerebral perfusion
Interventions/Control_2
Conventional retrograde cerebral perfusion
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing total arch replacement via midline incision
2. Patients undergoing the first-time cardiovascular operation
3. Patients given written informed consent
Key exclusion criteria
1. Patients having a history of cerebrovascular disease
2. Patients requiring emergency operation
3. Patients undergoing total arch replacement via left thoracotomy
4. Patients requiring concomitant valve or coronary-bypass operation
5. Severe liver disease
6. Severe renal disease
7. Patients whom physician judges inappropriate to the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Takamoto |
Organization
University of Tokyo
Division name
Cardiothoracic Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-Ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Ono |
Organization
University of Tokyo
Division name
Cardiothoracic Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Departments of Cardiothoracic Surgery, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2006 | Year | 06 | Month | 23 | 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
Date of protocol fixation
| 2006 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | 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
| 2006 | Year | 06 | Month | 23 | Day |
Last modified on
| 2006 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000529
