UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041856
Receipt number R000047784
Scientific Title effect of human recombinant thrombomodulin in sepsis due to intestinal perforation
Date of disclosure of the study information 2020/09/23
Last modified on 2020/09/22 01:23:20

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Basic information

Public title

effect of human recombinant thrombomodulin in sepsis

Acronym

rTM

Scientific Title

effect of human recombinant thrombomodulin in sepsis due to intestinal perforation

Scientific Title:Acronym

rTM-CHDF

Region

Japan


Condition

Condition

sepsis

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

effect of human recombinant thrombomodulin in sepsis due to intestinal perforation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

CHDF operation periods for 4 weeks

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

CHDF undergoing patients due to sepsis

Key exclusion criteria

none

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Kono

Organization

University of Yamanashi

Division name

First Department of Surgery

Zip code

409-3898

Address

1110 Shimokato, Chu-o, Yamanashi 409-3898, Japan

TEL

+81552737390

Email

hkouno@yamanashi.ac.jp


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Kono

Organization

University of Yamanashi

Division name

First Department of Surgery

Zip code

409-3898

Address

1110 Shimokato, Chu-o, Yamanashi 409-3898, Japan

TEL

+81552737390

Homepage URL


Email

hkouno@yamanashi.ac.jp


Sponsor or person

Institute

University of Yamanashi

Institute

Department

Personal name



Funding Source

Organization

University of Yamanashi

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Yamanashi

Address

1110 Shimokato, Chu-o, Yamanashi 409-3898, Japan

Tel

+81552737390

Email

hkouno@yamanashi.ac.jp


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



Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 23 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Open public recruiting

Date of protocol fixation

2020 Year 09 Month 12 Day

Date of IRB

2019 Year 06 Month 01 Day

Anticipated trial start date

2020 Year 09 Month 12 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 09 Month 22 Day

Last modified on

2020 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047784


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name