UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000231 |
|---|---|
| Receipt number | 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 15:10:54 |
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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
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/
Sponsor or person
Institute
BHYPO Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000293
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
