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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014630
Receipt No. R000016815
Scientific Title The Safety and Effect of inhalation of hydrogen gas after lung transplantation.
Date of disclosure of the study information 2014/08/01
Last modified on 2016/08/10

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Basic information
Public title The Safety and Effect of inhalation of hydrogen gas after lung transplantation.
Acronym The Safety and Effect of inhalation of hydrogen gas after lung transplantation.
Scientific Title The Safety and Effect of inhalation of hydrogen gas after lung transplantation.
Scientific Title:Acronym The Safety and Effect of inhalation of hydrogen gas after lung transplantation.
Region
Japan

Condition
Condition Lung transplantation
Classification by specialty
Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study designed to investigate if inhalation of hydrogen gas can reduce ischemia-reperfusion after lung transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the incidence of primary graft dysfunction (PGD) and PGD grade.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 1.3% hydrogen gas inhalation for 24 hours
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients after lung transplantation who can be treatable at FiO2<0.67
Key exclusion criteria The patients after lung transplantation who can NOT be treatable at FiO2<0.67
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Meinoshin Okumura
Organization Osaka University Graduate school of Medicine
Division name General thoracic surgery
Zip code
Address 2-2 (L5) Yamadaoka Suita City Osaka Japan
TEL 06-6879-3152
Email meinosin@thoraicc.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Kawamura
Organization Osaka University Graduate school of Medicine
Division name General thoracic surgery
Zip code
Address 2-2 (L5) Yamadaoka Suita City Osaka Japan
TEL 06-6879-3152
Homepage URL
Email tkawamu@thoracic.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate school of Medicine
Institute
Department

Funding Source
Organization Grants-in-aid for scientific research
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2014 Year 08 Month 01 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
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 23 Day
Last modified on
2016 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016815

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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