UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014630 |
|---|---|
| Receipt number | 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 13:19:05 |
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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
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
tkawamu@thoracic.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate school of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016815
