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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043745
Receipt No. R000049941
Scientific Title Efficacy of a recombinant antithrombin preparation for the treatment of intra-abdominal infectious DIC
Date of disclosure of the study information 2021/04/02
Last modified on 2021/03/25

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Basic information
Public title Efficacy of a recombinant antithrombin preparation for the treatment of intra-abdominal infectious DIC
Acronym Efficacy of a recombinant antithrombin preparation for the treatment of intra-abdominal infectious DIC
Scientific Title Efficacy of a recombinant antithrombin preparation for the treatment of intra-abdominal infectious DIC
Scientific Title:Acronym Efficacy of a recombinant antithrombin preparation for the treatment of intra-abdominal infectious DIC
Region
Japan

Condition
Condition septic DIC
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 n the case of intra-abdominal infection, a large amount of bacterial components and related substances are released into the intra-abdominal cavity and microvessels, exposing multiple organs to them, causing severe septic DIC in a short period of time. Therefore, in this study, we decided to evaluate the effect of rAT compared with dried concentrated human AT on DIC withdrawal and improvement of organ symptoms in a retrospective manner.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in DIC improvement rate within 7 days of onset
Key secondary outcomes Physiological severity and organ damage, AT activity level, 28-day mortality

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
18 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients aged 18 years or older diagnosed with septic DIC caused by intra-abdominal infection treated in the Intensive Care Unit of our hospital between April 1, 2014 and July 31, 2020.
Key exclusion criteria Pregnant women, patients with end-stage cancer, patients with cirrhosis, patients who do not meet the diagnostic criteria for acute DIC
Target sample size 200

Research contact person
Name of lead principal investigator
1st name yoshinoti
Middle name
Last name Tanigawa
Organization Saga University hospital
Division name Anesthesiology and Critical Care Medicins
Zip code 849-8501
Address 5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
TEL +81952343370
Email e6580@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name yoshinori
Middle name
Last name tanigawa
Organization Saga University Hospital
Division name Anesthesiology and Critical Care Medicins
Zip code 849-8501
Address 5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
TEL +81952343370
Homepage URL
Email e6580@cc.saga-u.ac.jp

Sponsor
Institute Saga university hospital
Institute
Department

Funding Source
Organization Saga university hospital
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 Saga Medical School Hospital
Address 5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
Tel +81952343370
Email e6580@cc.saga-u.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
2021 Year 04 Month 02 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 02 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observation study

Management information
Registered date
2021 Year 03 Month 25 Day
Last modified on
2021 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049941

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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