UMIN-CTR Clinical Trial

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