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Recruitment status
Unique ID issued by UMIN C000000435
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Departments of Cardiothoracic Surgery, the University of Tokyo
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000529

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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