UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study to evaluate the usefulness of thrombomodulin-alpha in patients with severe acute pancreatitis.
Title of the study (Brief title)	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	Masatoshi Mabuchi
Organization	Teikyo University Mizonokuchi Hospital
Division name	Department of Gastroenterology
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	Masatoshi Mabuchi
Organization	Teikyo University Mizonokuchi Hospital
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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