UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029126 |
|---|---|
| Receipt number | 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 11:16:45 |
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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
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
masatoshi.mabuchi@gmail.com
Sponsor or person
Institute
rTM for SAP study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032701
