UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045807 |
|---|---|
| Receipt number | R000052295 |
| Scientific Title | Survival assessment for patients requiring pleural or pericardial draiange after cardiac surgeries |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2021/10/20 16:10:00 |
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Basic information
Public title
Survival assessment for patients requiring pleural or pericardial draiange after cardiac surgeries
Acronym
Survival assessment for patients requiring pleural or pericardial draiange after cardiac surgeries
Scientific Title
Survival assessment for patients requiring pleural or pericardial draiange after cardiac surgeries
Scientific Title:Acronym
Survival assessment for patients requiring pleural or pericardial draiange after cardiac surgeries
Region
| Japan |
Condition
Condition
Postpericardiotomy syndrome
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to investigate the impact of severe postpericardiotomy syndrome requiring pleural or pericardial drainage on mid-term survival.
Basic objectives2
Others
Basic objectives -Others
The mid-term survival results of patients with or without severe PPS were analyzed using Kaplan-Meier curves and Cox analysis.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mid-term survival rate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients underwent cardiac or thoracic aortic surgeries requiring median sternotomy
Key exclusion criteria
No exclusion
Target sample size
487
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Nakatsu |
Organization
Kansai Electric Power Hospital
Division name
Division of Cardiovascular Surgery
Zip code
5530003
Address
Fukusima 2-1-7, Fukushima-ku, Osaka
TEL
0664585821
tnakatsu79@gmail.com
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Nakatsu |
Organization
Kansai Electric Power Hospital
Division name
Division of Cardiovascular Surgery
Zip code
5530003
Address
Fukusima 2-1-7, Fukushima-ku, Osaka
TEL
0664585821
Homepage URL
tnakatsu79@gmail.com
Sponsor or person
Institute
Japanese Red Cross Osaka Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of the Japanese Red Cross Osaka Hospital
Address
Fudegasaki-cho 5-30, Tennnouji-ku, Osaka
Tel
0667745111
soumuka@osaka-med.jrc.or.jp
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
| 2021 | Year | 10 | Month | 20 | 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
487
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a retrospective, single-center, observational study. A total of 487 patients who underwent cardiac or thoracic aortic surgery at the Japanese Red Cross Osaka Hospital between 2013 and 2018 required median sternotomy and pericardiotomy.
Management information
Registered date
| 2021 | Year | 10 | Month | 20 | Day |
Last modified on
| 2021 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052295
