UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018607
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yusuke_232002@yahoo.co.jp

Sponsor
Institute Yokohama city university, Depertment of gastroenterologicl surgery
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


Contact us.