UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053413 |
|---|---|
| Receipt number | R000060959 |
| Scientific Title | Transition of the criteria for disseminated intravascular coagulation used for randomized controlled trial |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2024/01/23 00:55:37 |
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Basic information
Public title
Transition of the criteria for disseminated intravascular coagulation used for randomized controlled trial
Acronym
Transition of disseminated intravascular coagulation criteria
Scientific Title
Transition of the criteria for disseminated intravascular coagulation used for randomized controlled trial
Scientific Title:Acronym
Transition of disseminated intravascular coagulation criteria
Region
| Japan |
Condition
Condition
Sepsis induced disseminated intravascular coagulation
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this review is to conduct a scoping review to systematically map the diagnostic criteria of sepsis-induced DIC used in RCTs and to identify the temporal trend of the popular criteria.
Basic objectives2
Others
Basic objectives -Others
descriptive study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The criterion for DIC which was used for RCT
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Studies that meet the following criteria
1. sepsis, 2. anticoagulants, 3. RCTs
Key exclusion criteria
Not applicable due to meta-analysis
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Matsuoka |
Organization
Keio university
Division name
Emergency medicine
Zip code
1600016
Address
35 SHINANOMACHI SHINJUKU-KU, Tokyo, Japan
TEL
0332251323
tadashi_matsuoka1984@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Matsuoka |
Organization
Keio university
Division name
Emergency Medicine
Zip code
160-0016
Address
35 SHINANOMACHI SHINJUKU-KU
TEL
0332251323
Homepage URL
tadashi_matsuoka1984@yahoo.co.jp
Sponsor or person
Institute
Keio university
Institute
Department
Personal name
Funding Source
Organization
None
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
none due to the study characteristics
Address
none due to the study characteristics
Tel
none due to the study characteristics
none due to the study characteristics
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 | 01 | Month | 31 | 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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We identified 8150 potential eligible articles for sepsis at the initial search (Table S1), of which 6533 articles remained after de-duplicating citations. After screening the titles and abstracts, 6470 were found to be non-relevant and were excluded. The remaining 63 articles were retrieved for eligibility assessment. Among them, 42 were excluded, leaving 21 trials. In sepsis induced DIC/coagulopathy, the study design included randomized control trial (RCT) (n = 13) and post-hoc analysis of RCTs (n=8). Number pf patients range from 30 to 2000 participants, and most studies included patient in only ICU patients.
Management information
Registered date
| 2024 | Year | 01 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060959
| 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 |
