UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002157 |
|---|---|
| Receipt number | R000002635 |
| Scientific Title | Coagulation variability and pharmacokinetics of thrombomodulin alfa. |
| Date of disclosure of the study information | 2009/07/02 |
| Last modified on | 2012/05/11 05:31:29 |
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Basic information
Public title
Coagulation variability and pharmacokinetics of thrombomodulin alfa.
Acronym
Coagulation variability and pharmacokinetics of thrombomodulin alfa.
Scientific Title
Coagulation variability and pharmacokinetics of thrombomodulin alfa.
Scientific Title:Acronym
Coagulation variability and pharmacokinetics of thrombomodulin alfa.
Region
| Japan |
Condition
Condition
patients with DIC
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate coagulation variability and pharmacokinetics of thrombomodulin alfa
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
concentration of TM
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with DIC are administrated thrombomodulin alfa.
Key exclusion criteria
non
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineji Hayakawa |
Organization
Hokkaido University Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
N14W5 Kita-ku, Sapporo 060-8648 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hokkaido University Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Emergency and Critical Care Center, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido 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
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
| 2009 | Year | 07 | Month | 02 | 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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prothrombinase activity
soluble thrombomodulin
protein C
soluble fibrin
TAT
TAFIa
Creatinine crearance
SOFA score
APACHE II score
general laboratory test
Management information
Registered date
| 2009 | Year | 07 | Month | 02 | Day |
Last modified on
| 2012 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002635
