UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023470 |
|---|---|
| Receipt number | R000027044 |
| Scientific Title | A study for development of reagents for sepsis with HISCL |
| Date of disclosure of the study information | 2016/08/10 |
| Last modified on | 2022/02/07 15:41:33 |
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Basic information
Public title
A study for development of reagents for sepsis with HISCL
Acronym
A study for development of reagents for sepsis with HISCL
Scientific Title
A study for development of reagents for sepsis with HISCL
Scientific Title:Acronym
A study for development of reagents for sepsis with HISCL
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirming the efficacy of the reagents for sepsis with HISCL by checking clinical samples
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing new reagents for sepsis with existing reagents (Preseason kit) and checking correlativity
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
over 18 years old
severe sepsis, severe trauma and burn, post cardiac arrest syndrome
Key exclusion criteria
patients whom researcher judged as mismatched to this research
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineji Hayakawa |
Organization
Hokkaido University Hospital
Division name
Emergency and critical care center
Zip code
Address
nishi 7 kita 15 kitaku Sapporo, Hokkaido, 064-0811, Japan
TEL
011-706-7377
mineji@dream.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mineji Hayakawa |
Organization
Hokkaido University Hospital
Division name
Emergency and critical care center
Zip code
Address
nishi 7 kita 15 kitaku Sapporo, Hokkaido, 064-0811, Japan
TEL
011-706-7377
Homepage URL
mineji@dream.com
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
Address
Tel
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
| 2016 | Year | 08 | Month | 10 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 02 | Month | 07 | Day |
Other
Other related information
Observational Study
Management information
Registered date
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2022 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027044
