UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022062
Receipt number R000025433
Scientific Title Motor Evoked Potential in Thoracic and Thoracoabdoinal Aneurysm Repair
Date of disclosure of the study information 2016/04/28
Last modified on 2021/05/29 15:41:44

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Basic information

Public title

Motor Evoked Potential in Thoracic and Thoracoabdoinal Aneurysm Repair

Acronym

MEPTRIAL

Scientific Title

Motor Evoked Potential in Thoracic and Thoracoabdoinal Aneurysm Repair

Scientific Title:Acronym

MEPTRIAL

Region

Japan


Condition

Condition

Thoracic and thoracoabdominal aneurysms

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy of motor evoked potentials and spinal drainage in thoracic and thoracoabodominal aortic repair

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Analysis of factors of reduction of motor evoked potentials

Key secondary outcomes

Analysis of association of motor evoked potentials and cerebrospinal drainage with postoperative motor deficits


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1,Patients with thoracic and thoracoabdominal aortic surgery from January,2001 to December, 2011
2, Patients with more than 20 years old

Key exclusion criteria

Patients without records of motor disfunction

Target sample size

1200


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Yoshitani

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Anesthesiology

Zip code

564-8565

Address

5-7-1 fujishirodai, Suita, Osaka, Japan

TEL

0661701070

Email

ykenji@ncvc.go.jp


Public contact

Name of contact person

1st name Kenji
Middle name YOSHITANI
Last name Yoshitani

Organization

National Cerebral & Cardiovascular Center

Division name

Department of Anesthesiology

Zip code

564-8565

Address

5-7-1 fujishirodai, Suita, Osaka, Japan

TEL

0661701070

Homepage URL


Email

ykenji@ncvc.go.jp


Sponsor or person

Institute

National Cerebral and Cardiovascular Center
Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

National Research Center

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cerebral & Cardiovascular Center

Address

6-1 Kishibe-Shimmachi, Suita, Osaka

Tel

0661701070

Email

ykenji@ncvc.go.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

2016 Year 04 Month 28 Day


Related information

URL releasing protocol

https://ncvc.bvits.com/rinri/Apply/project.aspx

Publication of results

Unpublished


Result

URL related to results and publications

https://ncvc.bvits.com/rinri/Apply/project.aspx

Number of participants that the trial has enrolled

1074

Results

MEP and CSFD were not associated with motor deficits at discharge.

Results date posted

2021 Year 05 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with descending and thoracoadmomimanal aortic repair

Participant flow

Enrollment from the list of surgery

Adverse events

None

Outcome measures

motor deficits at dischage

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 05 Month 01 Day

Date of IRB

2014 Year 06 Month 09 Day

Anticipated trial start date

2014 Year 06 Month 10 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2021 Year 05 Month 01 Day


Other

Other related information

retrospective multicenter study


Management information

Registered date

2016 Year 04 Month 25 Day

Last modified on

2021 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025433


Research Plan
Registered date File name
2021/05/29 MEDICAL 研究計画書ver 1.93.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name