UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030029
Receipt number R000034291
Scientific Title Biochemical studies of glucose and amino acid metabolism using blood, urine and cerebrospinal fluid for chronic severe traumatic head injury patients
Date of disclosure of the study information 2017/11/18
Last modified on 2018/11/19 09:07:48

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Basic information

Public title

Biochemical studies of glucose and amino acid metabolism using blood, urine and cerebrospinal fluid for chronic severe traumatic head injury patients

Acronym

Longitudinal biochemical studies for severe head injury patients

Scientific Title

Biochemical studies of glucose and amino acid metabolism using blood, urine and cerebrospinal fluid for chronic severe traumatic head injury patients

Scientific Title:Acronym

Longitudinal biochemical studies for severe head injury patients

Region

Japan


Condition

Condition

Chronic severe traumatic head injury

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To examine longitudinal change of severe head injury patients by genetic and biochemical studies

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Data of genetic and biochemical studies

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Subjects who admitted in Chiba Ryogo Center by the cause of severe traumatic head injury
2.Subjects who have medical stability and can perform examinations safely
3.Subjects who have provide informed consent by themselves or their family and adhere to the protocol

Key exclusion criteria

1.Subjects who have medical instability and cannot perform examinations safely
2.Subjects who cannot provide informed consent and adhere to the protocol
3.Subjects who are judged as not suitable for participation in this study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomohiro Yamaki, MD, PhD

Organization

Chiba Ryogo Center

Division name

Neurosurgery

Zip code


Address

3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, 261-0012, Japan

TEL

+81-43-277-0061

Email

t-yamaki@chiba-ryougo.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiro Yamaki, MD, PhD

Organization

Chiba Ryogo Center

Division name

Neurosurgery

Zip code


Address

3-30-1 Isobe, Mihama-ku, Chiba-shi, Chiba, 261-0012, Japan

TEL

+81-43-277-0061

Homepage URL


Email

t-yamaki@chiba-ryougo.jp


Sponsor or person

Institute

Chiba Ryogo Center

Institute

Department

Personal name



Funding Source

Organization

Chiba Ryogo Center

Organization

Division

Category of Funding Organization

Self funding

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

2017 Year 11 Month 18 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

Ongoing at 19 November 2018

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

Enrolling by invitation

Date of protocol fixation

2017 Year 11 Month 18 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 18 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Genetic and biochemical studies


Management information

Registered date

2017 Year 11 Month 18 Day

Last modified on

2018 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034291


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name