UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007965 |
|---|---|
| Receipt number | R000009379 |
| Scientific Title | Therapeutic effects of recombinant human soluble thrombomodulin in patients with DIC caused by severe burns:a historical control clinical trial. |
| Date of disclosure of the study information | 2012/05/16 |
| Last modified on | 2015/01/05 17:01:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Therapeutic effects of recombinant human soluble thrombomodulin in patients with DIC caused by severe burns:a historical control clinical trial.
Acronym
Therapeutic effects of rhTM in patients with DIC caused by severe burns:
a historical control clinical trial.
Scientific Title
Therapeutic effects of recombinant human soluble thrombomodulin in patients with DIC caused by severe burns:a historical control clinical trial.
Scientific Title:Acronym
Therapeutic effects of rhTM in patients with DIC caused by severe burns:
a historical control clinical trial.
Region
| Japan |
Condition
Condition
DIC caused by severe burns
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of rhTM in patients with DIC which caused by severe burns.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mortality in ICU (the interrelation between DIC remission rate and 28-day survival rete).
Key secondary outcomes
Mortality
Course of
DIC score
Clinical symptom
Blood clotting test
Inflammatory marker
APACHEII
HMGB1
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rhTM is administered at a dose of 0.06 mg/kg/day by intravenous drip for 30 minutes. This treatment is replaced once daily for 6 days.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who fills everything the following
(1)DIC established by JAAM (Japanese Association for Acute Medicine) DIC criteria>=4
(2)Severe burns as underlying diseases which directly caused DIC.(Burn Index>=10).
(3)Patient who gives written informed consent.
Key exclusion criteria
(1)Patients aged < 15 years.
(2)Patients showing intracranial, pulmonary or gastrointestinal hemo- rrhage.
(3)Patients with a history of hypersensitivity to rhTM.
(4)Pregnancy or possibly pregnancy.
(5)Other patients judged to be inappropriate at the discretion of investigators.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Morimura |
Organization
Yokohama City University Medical Center
Division name
Department of Emergency Medicine
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
molimula@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Yamamoto |
Organization
Yokohama City University Medical Center
Division name
Critical Care and Emergency Medical Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
molimula@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 16 | 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
| 2012 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
| 2012 | Year | 05 | Month | 16 | Day |
Last modified on
| 2015 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009379
