UMIN-CTR Clinical Trial

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
Email	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
Email	tnakatsu79@gmail.com

Sponsor
Institute	Japanese Red Cross Osaka Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052295