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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029126
Receipt No. R000032701
Scientific Title A prospective study to evaluate the usefulness of thrombomodulin-alpha in patients with severe acute pancreatitis.
Date of disclosure of the study information 2017/09/14
Last modified on 2017/09/13

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Basic information
Public title A prospective study to evaluate the usefulness of thrombomodulin-alpha in patients with severe acute pancreatitis.
Acronym Thrombomodulin alpha for severe acute pancreatitis.
Scientific Title A prospective study to evaluate the usefulness of thrombomodulin-alpha in patients with severe acute pancreatitis.
Scientific Title:Acronym Thrombomodulin alpha for severe acute pancreatitis.
Region
Japan

Condition
Condition Severe acute pancreatitis
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness and safety of thrombomodulin-alpha in patients with DIC due to severe acute pancreatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall survival at the 28 day after onset of pancreatitis
Key secondary outcomes Prognostic score, occurrence of local complications, and performance status of the patients at the 28 day after onset of the pancreatitis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of thrombomodulin-alpha
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 severe acute pancreatitis (prognostic factor score; 3 and more according to the JPS 2015 score) and DIC.
Key exclusion criteria Patients with allergy for thrombomodulin alpha.
Pregnant patients or patients who were suspected pregnancy.
Patients whose informed consent could not be obtained.
In case that doctors judged inappropriate for the entry.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Mabuchi
Organization Teikyo University Mizonokuchi Hospital
Division name Department of Gastroenterology
Zip code
Address 5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa 213-8507 JAPAN
TEL 044-844-3333
Email masatoshi.mabuchi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Mabuchi
Organization Teikyo University Mizonokuchi Hospital
Division name Department of Gastroenterology
Zip code
Address 5-1-1 Futago, Takatsu-ku, Kawasaki, Kanagawa 213-8507 JAPAN
TEL 044-844-3333
Homepage URL
Email masatoshi.mabuchi@gmail.com

Sponsor
Institute rTM for SAP study group
Institute
Department

Funding Source
Organization None
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 帝京大学医学部附属溝口病院

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 14 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 15 Day
Last follow-up date
2018 Year 07 Month 31 Day
Date of closure to data entry
2018 Year 08 Month 31 Day
Date trial data considered complete
2018 Year 10 Month 31 Day
Date analysis concluded
2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 13 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032701

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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