UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012548 |
|---|---|
| Receipt number | R000014608 |
| Scientific Title | Evaluation of the Surgical DIC Trial with Antithrombin and Recombinant thrombomodulin Study Group |
| Date of disclosure of the study information | 2013/12/11 |
| Last modified on | 2013/12/11 15:27:29 |
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Basic information
Public title
Evaluation of the Surgical DIC Trial with Antithrombin and Recombinant thrombomodulin Study Group
Acronym
ESTAR
Scientific Title
Evaluation of the Surgical DIC Trial with Antithrombin and Recombinant thrombomodulin Study Group
Scientific Title:Acronym
ESTAR
Region
| Japan |
Condition
Condition
Inclusion Criteria
Patient with 24 hours or more after surgical intervention.
Over 4 points by Disseminated intravascular coagulation diagnostic criteria established by the Japanese Association for Acute Medicine
Antithrombin activity below 50%.
Sepsis criteria of SCCM/ACCP
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Oto-rhino-laryngology |
| Orthopedics | Urology | Anesthesiology |
| Oral surgery | Neurosurgery | Cardiovascular surgery |
| Plastic surgery | Aesthetic surgery | Laboratory medicine |
| Operative medicine | Emergency medicine | Blood transfusion |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effective treatment of anticoagulant therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of coagulation markers at day4.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
once daily intravenous infusion of 3000 unit of antithrombin concentrate
Interventions/Control_2
intravenous infusion of 380 unit/kg of recombinant human soluble thrombomodulin after infusion of 1500 unit of antithrombin concentrate. (Pateint with renal failure with eGRF below 30 will be treated 130 unit/kg)
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
Inclusion Criteria
Patient with 24 hours or more after surgical intervention.
Over 4 points by Disseminated intravascular coagulation diagnostic criteria established by the Japanese Association for Acute Medicine
Antithrombin activity below 50%.
Sepsis criteria of SCCM/ACCP
Key exclusion criteria
1.Under 20 years old
2.Patient who cannot obtained its consent
3.Patients who are inadequate to enter this study due to other reasons by physician's judgments.
1.Leukemia
2.Patient treated with radiation/anticancer drug
3.Cirrhosis with Child-Pugh grade C or over
4.Patient with hemorrhagic disease (e.g. peptic ulcer after cerebral hemorrhage)
5.Patients with return of cardiopulmonary arrest
6.Patients who cannot survive after 28days judged by physician
7.Patients with past history of hypersensitivity to ATIII concentrate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Eguchi |
Organization
Shiga university of medical science
Division name
Department of Emergency and Intensive care
Zip code
Address
Tsukinowa town Seta Otsu city Shiga prefecture
TEL
077-548-2111
eguchi@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Eguchi |
Organization
Shiga university of medical science
Division name
Department of Emergency and Intensive care
Zip code
Address
Tsukinowa town Seta Otsu city Shiga prefecture
TEL
077-548-2111
Homepage URL
eguchi@belle.shiga-med.ac.jp
Sponsor or person
Institute
EASTAR workshop
Institute
Department
Personal name
Funding Source
Organization
EASTAR workshop
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 12 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | 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
| 2013 | Year | 12 | Month | 11 | Day |
Last modified on
| 2013 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014608
| 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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