UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002705 |
|---|---|
| Receipt number | R000003297 |
| Scientific Title | Randomized controlled trial: Combination therapy of Antithrombin and Recombinant-thrombomodulin for septic DIC |
| Date of disclosure of the study information | 2009/11/10 |
| Last modified on | 2024/05/16 15:29:11 |
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Basic information
Public title
Randomized controlled trial: Combination therapy of Antithrombin and Recombinant-thrombomodulin for septic DIC
Acronym
Combination therapy of Antithrombin and Thrombomodulin
Scientific Title
Randomized controlled trial: Combination therapy of Antithrombin and Recombinant-thrombomodulin for septic DIC
Scientific Title:Acronym
Combination therapy of Antithrombin and Thrombomodulin
Region
| Japan |
Condition
Condition
Sepsis associated with disseminated intravascular coagulation (DIC)
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the combination efficacy of Antithrombin and Recombinant-thrombomodulin for septic DIC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of DIC score, coagulation and fibrinolytic markers six days after thrombomodulin
Key secondary outcomes
Twenty-eight day mortality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antithrombin III, Three days, 1500IU, one administration/day
Interventions/Control_2
Antithrombin III, Three days 1500IU, one administration/day;thorombomodulin, Six days, 380IU/Kg, one administration/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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)ACCP/SCCM-defined sepsis criteria, 2)Japanese Association for Acute Medicine-defined DIC criteria score > 4
Key exclusion criteria
1)< Fifteen years of age, 2)Hematopoetic malignancy, 3)Comcomitant treatment with cartinostatics or irradiation, 4)Liver cirrhosis classified as Child-Pugh C
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomotsugu |
| Middle name | |
| Last name | Yasuda |
Organization
Kagoshima University Hospital
Division name
Intensive Care Units
Zip code
890-8520
Address
8-35-1 Sakuragaoka Kagoshima City
TEL
099-275-5649
yasutomo@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomotsugu |
| Middle name | |
| Last name | Yasuda |
Organization
Kagoshima University Hospital
Division name
Intensive Care Units
Zip code
890-8520
Address
8-35-1 Sakuragaoka Kagoshima City
TEL
099-275-5649
Homepage URL
yasutomo@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital Intensive Care Units
Institute
Department
Personal name
Funding Source
Organization
Kagoshima 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
Kagoshima University Hospital
Address
8-35-1 Sakuragaoka Kagoshima City
Tel
099-275-5646
yasutomo@m.kufm.kagoshima-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
| 2009 | Year | 11 | Month | 10 | 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
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | 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
| 2009 | Year | 11 | Month | 03 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003297
