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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010616
Receipt No. R000011873
Scientific Title A clinical trial of sternal closure with rigid plate fixation (SternaLock Blu) in cardiothoracic surgery
Date of disclosure of the study information 2013/05/07
Last modified on 2013/10/30

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Basic information
Public title A clinical trial of sternal closure with rigid plate fixation (SternaLock Blu) in cardiothoracic surgery
Acronym Sternal closure with rigid plate fixation
Scientific Title A clinical trial of sternal closure with rigid plate fixation (SternaLock Blu) in cardiothoracic surgery
Scientific Title:Acronym Sternal closure with rigid plate fixation
Region
Japan

Condition
Condition Aortic stenosis, Aortic regurgitation, Mitral stenosis, Mitral regurgitation, Tricuspid regurgitation
Classification by specialty
Vascular surgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this studyis to investigate the efficacy and safety of rigid sternal fixation with plates.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Death
Infection
Revision for bleeding
Key secondary outcomes Pain scale
The aoumont of analgesic drug usage
Pulmonary function
Total amount of drain discharge
Computed tomography

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 sternal plate
Interventions/Control_2 sternal wire
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
80 years-old >
Gender Male and Female
Key inclusion criteria valvular heart disease
Key exclusion criteria congestive heart failure
concomittant coronary artery bypass surgery
octogenearian
less than 20 years old
emergent case
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Yaku
Organization Koyoto Prefectural University of Medecine
Division name Cardiovascular Surgery
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL 075-251-5752
Email suguru19820411@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Suguru Ohira
Organization Koyoto Prefectural University of Medecine
Division name Cardiovascular Surgery
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566 Japan
TEL 075-251-5752
Homepage URL
Email s-ohira@koto.kpu-m.ac.jp

Sponsor
Institute Department of Cardiovascular Surgery, Koyoto Prefectural University of Medecine
Institute
Department

Funding Source
Organization Medical U&A, Inc.
Organization
Division
Category of Funding Organization Profit organization
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 京都府立医科大学 心臓血管外科

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 07 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
2013 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 07 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 09 Month 30 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 30 Day
Last modified on
2013 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011873

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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