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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000231
Receipt No. R000000293
Scientific Title Therapeutic Strategy for Severe Head Trauma Patients with Mild Hypothermia and Estimation of Medical Expenses in Japan.
Date of disclosure of the study information 2005/09/13
Last modified on 2014/09/24

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Basic information
Public title Therapeutic Strategy for Severe Head Trauma Patients with Mild Hypothermia and Estimation of Medical Expenses in Japan.
Acronym Therapeutic Strategy for Severe Head Trauma Patients with Mild Hypothermia and Estimation of Medical Expenses in Japan.
Scientific Title Therapeutic Strategy for Severe Head Trauma Patients with Mild Hypothermia and Estimation of Medical Expenses in Japan.
Scientific Title:Acronym Therapeutic Strategy for Severe Head Trauma Patients with Mild Hypothermia and Estimation of Medical Expenses in Japan.
Region
Japan

Condition
Condition Traumatic Brain Injuries
Classification by specialty
Anesthesiology Neurosurgery Emergency medicine
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this trial is to determine if mild hypothermia therapy for severe head trauma patients improves neurologial outcome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Neurological outcome (Glasgow outcome score and neuropsychological performance at 6 month after injury); Total medical expenses
Key secondary outcomes Physiological data; Laboratory data

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Mild hypothermia therapy ( 32.0 – 34.0 degree Celsius)
Interventions/Control_2 Anti-hyperthermia therapy ( 35.5 – 37.0 C )
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
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Traumatic brain injury, Glasgow coma score 4-8 ( motor 1-5 )
Hypothermia or anti-hyperthermia must be induced within 6 hours after injury
Key exclusion criteria Systolic blood pressure <90mmHg ( after resuscitation )
Thrombocytopenia ( Plt<50,000/mm3 )
pregnancy
preexisting medical conditions of severe hepatic dysfunction, heart failure or any other severe organ failure
deep drunkenness
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Maekawa
Organization Yamaguchi University Hospital
Division name Advanced Medical Emergency and Critical Care Center
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi, 7558505, Japan
TEL 0836-22-2343
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Maekawa
Organization Yamaguchi University Hospital
Division name Advanced Medical Emergency and Critical Care Center
Zip code
Address 1-1-1 Minamikogushi, Ube, Yamaguchi, 7558505, Japan
TEL 0836-22-2343
Homepage URL http://bhypo.umin.jp/
Email

Sponsor
Institute BHYPO Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare (JAPAN)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor University hospital Medical Information Network(UMIN, Japan)
Japan Clinical Research Support Unit(J-CRSU)
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00134472
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25099730
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
2002 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2002 Year 12 Month 01 Day
Last follow-up date
2008 Year 09 Month 01 Day
Date of closure to data entry
2008 Year 09 Month 01 Day
Date trial data considered complete
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2014 Year 09 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000293

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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