UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029775
Receipt number 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 15:45:22

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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 or person

Institute

shiga university of medical science

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034024


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name