UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018868 |
|---|---|
| Receipt number | R000021823 |
| Scientific Title | Anti-inflammatory and immunomodulative effects of human recombinant thrombomodulin for severe septic patients |
| Date of disclosure of the study information | 2015/08/31 |
| Last modified on | 2015/08/31 23:21:52 |
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Basic information
Public title
Anti-inflammatory and immunomodulative effects of human recombinant thrombomodulin for severe septic patients
Acronym
Anti-inflammatory and immunomodulative effects of human recombinant thrombomodulin
Scientific Title
Anti-inflammatory and immunomodulative effects of human recombinant thrombomodulin for severe septic patients
Scientific Title:Acronym
Anti-inflammatory and immunomodulative effects of human recombinant thrombomodulin
Region
| Japan |
Condition
Condition
Severe sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate anti-inflammatory and immunomodulative effects of human recombinant thrombomodulin for severe septic
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
lymphocyte number
DIC score
Cytokine levels
Key secondary outcomes
Mortality (28, 90, ICU, in-hospital)
ventilator days
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
Severe sepsis with DIC patients hospitalized tokai university hospital.
Key exclusion criteria
None
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeaki Inoue |
Organization
Tokai University, School of Medicine
Division name
Dept. of Emergency and Critical Care Medicine
Zip code
Address
Shimokasuya143 Isehara, Kanagawa, Japan
TEL
0463-93-1121
sg-inoue@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeaki Inoue |
Organization
Tokai University, School of Medicine
Division name
Dept. of Emergency and Critical Care Medicine
Zip code
Address
Shimokasuya143 Isehara, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
sg-inoue@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Inoue's Labo in Tokai University
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei pharma
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NOW underanalysis
Management information
Registered date
| 2015 | Year | 08 | Month | 31 | Day |
Last modified on
| 2015 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021823
