UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018280 |
|---|---|
| Receipt number | R000021159 |
| Scientific Title | Clinical study of the administration method of antithrombin agent |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2015/07/12 23:28:21 |
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Basic information
Public title
Clinical study of the administration method of antithrombin agent
Acronym
Clinical study of the administration method of antithrombin agent
Scientific Title
Clinical study of the administration method of antithrombin agent
Scientific Title:Acronym
Clinical study of the administration method of antithrombin agent
Region
| Japan |
Condition
Condition
sepsis indused disseminated intravascular coagulation
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether continuous administration of antithrombin agent or once-daily administration of antithrombin agent is more effective for sepsis indused DIC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disseminated intravascular coagulation resolution rates
Key secondary outcomes
28-day survival rate, AT activity change
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AT agent is administered at 1500 U once per day for 3 days
Interventions/Control_2
AT agent is administered by continuous infusion 1500 U per day for 3 days, after 1000 U loading dose is administered
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
1. sepsis
2. JAAM DIC score is 4 or greater
3. AT activity is less than 70
Key exclusion criteria
1. other DIC agent for DIC treatment
2. use of anticoagulants, antiplatelet agents, antithrombotics, exception of heparin locks, heparin flushes or deep-vein thrombosis prophykaxis, and anticoaglants for renal replacement therapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Isotani |
Organization
Tokyo women's medical university
Division name
medical center east, Emergency and Critical Care Center
Zip code
Address
2-1-10 nishiogu, arakasa-ku, Tokyo
TEL
03-3810-1111
isotaner@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Takahashi |
Organization
Tokyo women's medical university
Division name
medical center east, Emergency and Critical Care Center
Zip code
Address
2-1-10 nishiogu, arakasa-ku, Tokyo
TEL
03-3810-1111
Homepage URL
htakahashi-tmd@umin.ac.jp
Sponsor or person
Institute
Tokyo women's medical university
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 07 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 12 | Day |
Last modified on
| 2015 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021159
