UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Biochemical studies of glucose and amino acid metabolism using blood, urine and cerebrospinal fluid for chronic severe traumatic head injury patients
Title of the study (Brief title)	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	Tomohiro Yamaki, MD, PhD
Organization	Chiba Ryogo Center
Division name	Neurosurgery
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	Tomohiro Yamaki, MD, PhD
Organization	Chiba Ryogo Center
Division name	Neurosurgery
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
Institute	Chiba Ryogo Center
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Ongoing at 19 November 2018
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034291