UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000029775
Receipt No. R000034024
Scientific Title Risk factors for early mortality after repair of acute type A aortic dissection.
Date of disclosure of the study information 2017/11/01
Last modified on 2020/05/04 (Ver. 5)

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Basic information
Public title Risk factors for early mortality after repair of acute type A aortic dissection.
Acronym Early result of acute type A dissection
Scientific Title Risk factors for early mortality after repair of acute type A aortic dissection.
Scientific Title:Acronym Early result of acute type A dissection
Region
Japan

Condition
Condition acute type A aortic dissection
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Risk factors for early mortality after repair of acute type A aortic dissection were evaluated based on various considerations such as preoperative patient comorbidities, dissection-related status, and operative procedure.
Basic objectives2 Others
Basic objectives -Others The present study evaluated the risk factors for surgical mortality and morbidity after emergent repair of acute type A aortic dissection based on various considerations such as preoperative patient comorbidities, dissection-related status, and operative procedure.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hospital mortality
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
28 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria all patients who underwent surgey
Key exclusion criteria non
Target sample size 350

Research contact person
Name of lead principal investigator
1st name tomoaki
Middle name
Last name suzuki
Organization cardiovascular surgery
shiga university of medical science
Division name cardiovascular surgery
Zip code 520-2192
Address setatsukinowacho
TEL 077-548-2244
Email suzukit@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name tomoaki
Middle name
Last name suzuki
Organization shiga university of medical science
Division name cardiovascular surgery
Zip code 520-2192
Address setatsukinowacho
TEL 077-548-2244
Homepage URL
Email suzukit@belle.shiga-med.ac.jp

Sponsor
Institute shiga university of medical science
Institute
Department

Funding Source
Organization shiga university of medical science
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 shiga university of medical science
Address setatsukinowacho
Tel 077-548-2244
Email suzukit@belle.shiga-med.ac.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
2017 Year 11 Month 01 Day

Related information
URL releasing protocol Risk factors for early mortality after repair of acute type A aortic dissection.
Publication of results Published

Result
URL related to results and publications Risk factors for early mortality after repair of acute type A aortic dissection.
Number of participants that the trial has enrolled 313
Results 
From April 2003 to Septe,ber 2017,313 patients underwent surgical repair for acute type A aortic dissection.Hospital mortality occurred in 32 patients.
 Multivariable logistic regression analysis revealed that preoperative cardiopulmonary resuscitation, cardiac tamponade,chronic pulmonary disease, hemodialysis, and longer CPB time were independent risk factor for early death.
Results date posted
2020 Year 05 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
From April 2003 to September 2017, 313 patients underwent surgical repair for acute type A aortic dissection at our institution.
Participant flow 
From April 2003 to September 2017, 313 patients underwent surgical repair for acute type A aortic dissection at our institution.
Adverse events 
no
Outcome measures 
hospital death
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
2017 Year 10 Month 19 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information non

Management information
Registered date
2017 Year 10 Month 31 Day
Last modified on
2020 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034024