UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038183
Receipt number R000041675
Scientific Title A retrospective study of the predominant leak site of cerebrospinal fluid hypovolemia
Date of disclosure of the study information 2019/10/02
Last modified on 2019/12/03 15:17:07

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Basic information

Public title

A retrospective study of the predominant leak site of cerebrospinal fluid hypovolemia

Acronym

RPC study

Scientific Title

A retrospective study of the predominant leak site of cerebrospinal fluid hypovolemia

Scientific Title:Acronym

RPC study

Region

Japan


Condition

Condition

cerebrospinal fluid hypovolemia

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine about the predominant leak site of cerebrospinal fluid hypovolemia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We identify the leakage site by examination and clinical judgment and perform blood patch. We estimate the leak site from these test results and the treatment effect, and examine the predominant leak site.

Key secondary outcomes

We evaluate the effectiveness and safety of Overflow leak test.


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 who received a blood patch after being diagnosed with cerebrospinal fluid reduction at our facility.

Key exclusion criteria

N/A

Target sample size

14


Research contact person

Name of lead principal investigator

1st name Eiichi
Middle name
Last name Nakai

Organization

Kochi Medical School Hospital

Division name

Neurosurgery

Zip code

783-8505

Address

Kohasu, Okocho, Nankoku, Kochi 783-8505, JAPAN

TEL

088-880-2397

Email

enakai@kochi-u.ac.jp


Public contact

Name of contact person

1st name Eiichi
Middle name
Last name Nakai

Organization

Kochi Medical School Hospital

Division name

Neurosurgery

Zip code

783-8505

Address

Kohasu, Okocho, Nankoku, Kochi 783-8505, JAPAN

TEL

088-880-2397

Homepage URL


Email

enakai@kochi-u.ac.jp


Sponsor or person

Institute

Kochi Medical School Hospital
Neurosurgery

Institute

Department

Personal name



Funding Source

Organization

N/A

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

Kochi Medical School Hospital

Address

Kohasu, Okocho, Nankoku, Kochi 783-8505, JAPAN

Tel

088-880-2397

Email

enakai@kochi-u.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

2019 Year 10 Month 02 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

Completed

Date of protocol fixation

2019 Year 05 Month 01 Day

Date of IRB

2019 Year 06 Month 10 Day

Anticipated trial start date

2019 Year 05 Month 01 Day

Last follow-up date

2019 Year 05 Month 31 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete

2019 Year 12 Month 31 Day

Date analysis concluded

2019 Year 12 Month 31 Day


Other

Other related information

N/A


Management information

Registered date

2019 Year 10 Month 02 Day

Last modified on

2019 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041675


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name