UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043745 |
|---|---|
| Receipt number | 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 19:55:30 |
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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
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
e6580@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049941
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
