UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018074 |
|---|---|
| Receipt number | R000020585 |
| Scientific Title | Evaluation of anthithrombin III therapeutic effect by frequency of administration in sepsis-associated disseminated intravascular coagulation |
| Date of disclosure of the study information | 2015/06/24 |
| Last modified on | 2019/10/16 12:14:19 |
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Basic information
Public title
Evaluation of anthithrombin III therapeutic effect by frequency of
administration in sepsis-associated disseminated intravascular coagulation
Acronym
Evaluation of anthithrombin III therapeutic effect in sepsis
Scientific Title
Evaluation of anthithrombin III therapeutic effect by frequency of
administration in sepsis-associated disseminated intravascular coagulation
Scientific Title:Acronym
Evaluation of anthithrombin III therapeutic effect in sepsis
Region
| Japan |
Condition
Condition
Sepsis-associated disseminated intravascular coagulation
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate administration frequency for anti-thrombin III in disseminated intravascular coagulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The period of improving DIC.
Key secondary outcomes
Improvment of coagurative and inflammatory marker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1500U of AT was administered to the patients once a day
Interventions/Control_2
500U of AT was administered to the patients three times a day
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
The patient of sepsis-associated disseminated intravascular coagulation which was indicated under 70% of AT III activity.
Key exclusion criteria
Age: under 20 years old
Hematopoietic malignancy such as lykemia
Patient under the anticoagulan treatment such as heparin or warfarin
Liver cirrhosis (Child-Pugh score C)
The patient will die within a few days regardless of treatment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Yasuda |
Organization
Gifu University Hospital
Division name
Advanced Critical Care Center
Zip code
Address
1-1 Yanagido, Gifu Japan
TEL
058-230-6448
yasuryu@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryu Yasuda |
Organization
Gifu University Hospital
Division name
Advanced Critical Care Center
Zip code
Address
1-1 Yanagido, Gifu Japan
TEL
058-230-6448
Homepage URL
yasuryu@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
CSL Behring
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 06 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 24 | Day |
Last modified on
| 2019 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020585
| 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 |
