UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009460 |
|---|---|
| Receipt number | R000011100 |
| Scientific Title | Which is effective and safe for persistent pulmonary hypertension after pulmonary endarterectomy, NO or Flolan? |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2015/06/18 08:49:11 |
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Basic information
Public title
Which is effective and safe for persistent pulmonary hypertension after pulmonary endarterectomy, NO or Flolan?
Acronym
Which is effective and safe for persistent pulmonary hypertension after pulmonary endarterectomy, NO or Flolan?
Scientific Title
Which is effective and safe for persistent pulmonary hypertension after pulmonary endarterectomy, NO or Flolan?
Scientific Title:Acronym
Which is effective and safe for persistent pulmonary hypertension after pulmonary endarterectomy, NO or Flolan?
Region
| Japan |
Condition
Condition
persistent pulmonary hypertension after pulmonary endarterectomy
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal which inhalation therapy is more effective and safe for persistent pulmonary hypertension after pulmonary endarterectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
effectiveness of lowering pulmonary artery pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
NO inhalation therapy will begin, if the patient develops pulmonary hypertension (mean pulmonary artery pressure above 25 mmHg) after separation from cardiopulmonary bypass. NO therpy will stop, if pulmonary hypertension relieves or the patient is extubated.
Interventions/Control_2
Flolan inhalation therapy will begin, if the patient develops pulmonary hypertension (mean pulmonary artery pressure above 25 mmHg) after separation from cardiopulmonary bypass. Flolan therpy will stop, if pulmonary hypertension relieves or the patient is extubated.
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 patient who develops pulmonary hypertension (mean pulmonary artery pressure above 25 mmHg) after separation from cardiopulmonary bypass.
Key exclusion criteria
patients with bleeding complication will be excluded.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Ishida |
Organization
Chiba University Hospital
Division name
Dept. of Cardiovascular Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432262733
keiichi-ishida@pro.odn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Ishida |
Organization
Chiba University Hospital
Division name
Dept.of Cardiovascular Surgery
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
0432262733
Homepage URL
keiichi-ishida@pro.odn.ne.jp
Sponsor or person
Institute
Dept. of Cardiovascular Surgery, Chiba University Hospital
Institute
Department
Personal name
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
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
| 2013 | Year | 01 | 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
We found no differences in pulmonary and systemic hemodynamics between patients treated with NO and floran inhalation.
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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 03 | Day |
Last modified on
| 2015 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011100
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