UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000882 |
|---|---|
| Receipt number | R000001064 |
| Scientific Title | Treatment effects of antithrombin in septic patients with disseminated intravascular coagulation (DIC). |
| Date of disclosure of the study information | 2007/12/01 |
| Last modified on | 2012/11/08 11:18:54 |
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Basic information
Public title
Treatment effects of antithrombin in septic patients with disseminated intravascular coagulation (DIC).
Acronym
Antithrombin and sepsis-associated DIC.
Scientific Title
Treatment effects of antithrombin in septic patients with disseminated intravascular coagulation (DIC).
Scientific Title:Acronym
Antithrombin and sepsis-associated DIC.
Region
| Japan |
Condition
Condition
Sepsis associated with disseminated intravascular coagulation (DIC).
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that antithrombin treatment improves prognosis of septic patients with disseminated intravascular coagulation (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 on the four days after antithrombin treatment.
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
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antithrombin III, Three days, 30 IU/kg, One administration/day
Interventions/Control_2
No treatment.
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, 3) Antithrombin level >50% and <80%. The patient fulfilles 1), 2), and 3).
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, 5) Early phase of trauma and burn injury.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Gando |
Organization
Hokkaido University Graduate School of Medicine
Division name
Acute and Critical Care Medicine
Zip code
Address
N17 W5, Kita-ku, Sapporo
TEL
011-706-7377
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Gando |
Organization
Hokkaido University Graduate School of Medicine
Division name
Acute and Critical Care Medicine
Zip code
Address
N17 W5, Kita-ku, Sapporo
TEL
011-706-7377
Homepage URL
gando@med.hokudai.ac.jp
Sponsor or person
Institute
Japanese Association for Acute Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Acute Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2007 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2007 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 02 | Month | 17 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 08 | Day |
Last modified on
| 2012 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001064
