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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042963
Receipt No. R000049047
Scientific Title Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Date of disclosure of the study information 2021/01/10
Last modified on 2021/01/10

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Basic information
Public title Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Acronym Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Scientific Title Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Scientific Title:Acronym Prospective observational study investigating the association between post surgical chronic pain and cardiopulmonary bypass among patients undergoing coronary artery bypass graft.
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Surgery in general Vascular surgery Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association between post surgical chronic pain and culdiopulmonary bypass induced inflammation.
Basic objectives2 Others
Basic objectives -Others To investigate the association between post surgical chronic pain and culdiopulmonary bypass induced inflammation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of Numerical rating scale
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing bypass surgery for coronary artery disease
Key exclusion criteria Stroke, porcelain aorta, creatinine>=2.0, severe hiver dysfunction, LVEF<30%, COPD, redo surgery,
Target sample size 167

Research contact person
Name of lead principal investigator
1st name Kimito
Middle name
Last name Minami
Organization National cerebral and cardiovascular center
Division name Department of Surgical Intensive Care
Zip code 564-8565
Address 6-1 Kishibeshinmachi, Suita
TEL 0661701070
Email k.minami@ncvc.go.jp

Public contact
Name of contact person
1st name Kimito
Middle name
Last name Minami
Organization National cerebral and cardiovascular center
Division name Department of surgical intensive care
Zip code 564-8565
Address 6-1 Kishibeshinmachi, Suita
TEL 0661701070
Homepage URL
Email k.minami@ncvc.go.jp

Sponsor
Institute National cerebral and cardiovascular center
Institute
Department

Funding Source
Organization National cerebral and cardiovascular center
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 National cerebral and cardiovascular center
Address 6-1 Kishibeshinmachi, Suita
Tel 0661701070
Email k.minami@ncvc.go.jp

Secondary IDs
Secondary IDs YES
Study ID_1 R19031
Org. issuing International ID_1 National cerebral and cardiovascular center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 10 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 Enrolling by invitation
Date of protocol fixation
2019 Year 06 Month 06 Day
Date of IRB
2019 Year 06 Month 06 Day
Anticipated trial start date
2019 Year 06 Month 06 Day
Last follow-up date
2021 Year 01 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Investigate the difference in NRS score between on pump CABG versus off pump CABG

Management information
Registered date
2021 Year 01 Month 10 Day
Last modified on
2021 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049047

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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