UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043130 |
|---|---|
| Receipt number | R000049239 |
| Scientific Title | Potential mechanisms and its microRNA interactions of platelet reductions in patients with sepsis-induced coagulopathy (Prospective obserbational study) |
| Date of disclosure of the study information | 2021/01/25 |
| Last modified on | 2024/08/03 10:59:05 |
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Basic information
Public title
Sepsis and Platelet microRNA
Acronym
Sepsis and Platelet microRNA
Scientific Title
Potential mechanisms and its microRNA interactions of platelet reductions in patients with sepsis-induced coagulopathy (Prospective obserbational study)
Scientific Title:Acronym
Role of platelet microRNA in the pathogenesis of sepis
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Anesthesiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Elucidating the mechanisms of platelet reduction in sepsis and the role of platelet-derived microRNA in this process
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the differences in platelet messenger RNA and microRNA expression using next-generation sequencing, PCR, and other methods between patients with sepsis, distinguishing those with and without platelet reduction, and comparing these findings to non-sepsis patients.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with and without sepsis admitted to the ICU
Key exclusion criteria
Patients after scheduled surgery, Platelet and coagulation disorders including antithombotic drug therapy, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, patients with inflammatory diseases, or chromosomal abnormalities.
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Yasufumi |
| Middle name | |
| Last name | Nakajima |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
5731191
Address
Hirakatashi
TEL
09082118435
nakajiya@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yasufumi |
| Middle name | |
| Last name | Nakajima |
Organization
Kansai Medical University
Division name
Department of Anesthesiology
Zip code
5890014
Address
Hirakatashi
TEL
0723660221
Homepage URL
nakajima@med.kindai.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Kansai Medical University
Address
Hirakatashi
Tel
0728040101
kmuinfo@hirakata.kmu.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
| 2021 | Year | 01 | Month | 25 | 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
1. Empirical analysis of digital gene expression was performed using CLC Genomic Workbench (Qiagen, MA, USA) for comparison of the NGS-based results for mRNA expression. The results for mRNA expression were matched with data in the Ensembl database.
2.Ingenuity pathway analysis (IPA) (Qiagen, MA, USA) analysis to assess candidate pathways and gene expression patterns that exhibited statistically significant differences among groups for the genes identified by NGS analysis. Functional enrichment analysis using the STRING database.
3.mRNA and miRNA expression analysis by quantitative polymerase chain reaction (qPCR). Protein expression analysis by ELISA.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Obserbational Study
Management information
Registered date
| 2021 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049239
