UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033525
Receipt number R000038229
Scientific Title Efficacy of emergent cerebrospinal fluid drainage on spinal cord injury after aortic aneurysm repair
Date of disclosure of the study information 2018/07/30
Last modified on 2018/07/26 16:02:49

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Basic information

Public title

Efficacy of emergent cerebrospinal fluid drainage on spinal cord injury after aortic aneurysm repair

Acronym

Emergent cerebrospinal fluid drainage after aortic aneurysm repair

Scientific Title

Efficacy of emergent cerebrospinal fluid drainage on spinal cord injury after aortic aneurysm repair

Scientific Title:Acronym

Emergent cerebrospinal fluid drainage after aortic aneurysm repair

Region

Japan


Condition

Condition

aortic aneurysm

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We assess of the potential efficacy of emergent cerebrospinal fluid drainage (eCSFD) as a treatment for unpredicted neurological deficits caused by spinal cord ischemia after aortic aneurysm repair.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome is the improvement on the paraplegia scale by the time of discharge from the hospital.

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

35 years-old <=

Age-upper limit

88 years-old >

Gender

Male and Female

Key inclusion criteria

patients with neurological deficits after the aortic aneurysm repair

Key exclusion criteria

patients who had undergone CSFD before the repair or had paraparesis

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junji Nakazawa

Organization

Sapporo Medical University of Medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

Hokkaido prefecture Sapporo City South 1 West 16

TEL

0116112111

Email

bankara02@chic.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junji Nakazawa

Organization

Sapporo Medical University of Medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

Hokkaido prefecture Sapporo City South 1 West 16

TEL

0116112111

Homepage URL


Email

bankara02@chic.ocn.ne.jp


Sponsor or person

Institute

Sapporo Medical University of Medicine
Department of Cardiovascular Surgery

Institute

Department

Personal name



Funding Source

Organization

nothing

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


Address


Tel


Email



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

2018 Year 07 Month 30 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


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

Preinitiation

Date of protocol fixation

2018 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

nothing


Management information

Registered date

2018 Year 07 Month 26 Day

Last modified on

2018 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038229


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name