UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018607 |
|---|---|
| Receipt number | R000021477 |
| Scientific Title | The efficacy of recombinant thrombomodulin in a patient with cholangitis with DIC |
| Date of disclosure of the study information | 2015/08/09 |
| Last modified on | 2015/08/09 07:15:32 |
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Basic information
Public title
The efficacy of recombinant thrombomodulin in a patient with cholangitis with DIC
Acronym
The efficacy of rTM in a patient with cholangitis with DIC
Scientific Title
The efficacy of recombinant thrombomodulin in a patient with cholangitis with DIC
Scientific Title:Acronym
The efficacy of rTM in a patient with cholangitis with DIC
Region
| Japan |
Condition
Condition
Cholangitis with DIC
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease | Hepato-biliary-pancreatic surgery |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To cralify efficacy and safty of recombinant-thrombomodulin in a patient with cholangitis with DIC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Duration of DIC, DIC resolution rates
Key secondary outcomes
survival rate in 28 days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Duration:From september 1st, 2015 to September 31st, 2019
Drug: Recombinant thrombomodulin
Times: 5 times generally
Interventions/Control_2
Control group
Duration:From september 1st, 2015 to September 31st, 2019
Drug: DIC drug without rTM
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with mild and moderate acute cholangitis (TG13) with DIC( Japanese Association for Acute Medicine-defined DIC criteria score>=4)
Key exclusion criteria
1. The patients with hemorrhagic lesion.
2. The patients with allergy in rTM.
3. the pregnancy patients
4. Non imformed consent
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsuyama Ryusei |
Organization
Yokohama city University
Division name
Depertment of gastroenterologicl surgery
Zip code
Address
3-13, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2650
ryusei@terra.dti.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Suwa |
Organization
Yokohama city university
Division name
Depertment of gastroenterologicl surgery
Zip code
Address
3-13, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2650
Homepage URL
yusuke_232002@yahoo.co.jp
Sponsor or person
Institute
Yokohama city university, Depertment of gastroenterologicl surgery
Institute
Department
Personal name
Funding Source
Organization
Yokohama city university, Depertment of gastroenterologicl surgery
Organization
Division
Category of Funding Organization
Self funding
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 09 | 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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 09 | Day |
Last modified on
| 2015 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021477
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
