UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054197 |
|---|---|
| Receipt number | R000061885 |
| Scientific Title | Comprehensive analysis of platelet RNA expression profiles in sepsis |
| Date of disclosure of the study information | 2024/04/22 |
| Last modified on | 2024/04/19 13:17:47 |
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Basic information
Public title
Genetic analysis in platelets of patients with infectious diseases
Acronym
Genetic analysis in platelets of patients with infectious diseases
Scientific Title
Comprehensive analysis of platelet RNA expression profiles in sepsis
Scientific Title:Acronym
Comprehensive analysis of platelet RNA expression profiles in sepsis
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We believe that excessive platelet activation and subsequent decrease in platelet cell count are the causes of exacerbation of inflammation in severe sepsis, which is associated with patient prognosis, and we aim to identify the mechanism and new preventive and therapeutic methods for severe sepsis.
Basic objectives2
Others
Basic objectives -Others
The mechanism by which impaired glucose tolerance is associated with excessive platelet activation and subsequent reduction in platelet cell count in patients with sepsis will also be analyzed
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in platelet mRNA and miRNA expression between septic and non-septic patients
Key secondary outcomes
1.Differences in platelet mRNA and miRNA expression between septic patients with diabetes mellitus and those without diabetes mellitus
2.Expression levels of related proteins
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. A person who enters the intensive care unit of this hospital (regardless of the condition that leads to the admission)
2. A person who receives a thorough explanation of his participation in this study, and gives his (or his surrogate's) free and voluntary written consent based on a thorough understanding of the situation.
Key exclusion criteria
1. A patient with significant anemia
2. A patient who takes antiplatelet or anticoagulant medication
3. Other person who is deemed by the principal investigator to be inappropriate to participate in the study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yasufumi |
| Middle name | |
| Last name | Nakajima |
Organization
Kindai University Faculty of Medicine
Division name
Deprtment of Anesthesiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osaka Sayama-shi, Osaka
TEL
072-366-0221
nakajima@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Houri |
Organization
Kindai University Faculty of Medicine
Division name
Deprtment of Anesthesiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osaka Sayama-shi, Osaka
TEL
072-366-0221
Homepage URL
labo.anesth.kindai@gmail.com
Sponsor or person
Institute
Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kinki university hospital clinical research center
Address
377-2, Ohnohigashi, Osaka Sayama-shi, Osaka
Tel
072-366-0221
zizen@med.kindai.ac.jp
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
| 2024 | Year | 04 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The principal investigator will discontinue this research if the ethics committee recommends or directs discontinuation of this research
Management information
Registered date
| 2024 | Year | 04 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061885
| 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 |
