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

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 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


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

Value
https://center6.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