UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010632 |
|---|---|
| Receipt number | R000012432 |
| Scientific Title | Efficacy and safety of recombinant human thrombomodulin for the patients with coagulopathy before cardiovascular surgery |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2013/05/01 16:16:19 |
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Basic information
Public title
Efficacy and safety of recombinant human thrombomodulin for the patients with coagulopathy before cardiovascular surgery
Acronym
Efficacy and safety of recombinant human thrombomodulin for DIC patients before cardiovascular surgery
Scientific Title
Efficacy and safety of recombinant human thrombomodulin for the patients with coagulopathy before cardiovascular surgery
Scientific Title:Acronym
Efficacy and safety of recombinant human thrombomodulin for DIC patients before cardiovascular surgery
Region
| Japan |
Condition
Condition
aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of recombinant human thrombomodulin for the patients with coagulopathy after cardiovascular surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
DIC score (at the day-6 after the commence of the treatment)
Key secondary outcomes
Blood clotting test findings
(FDP, Ddimer, TAT, PIC)
AT activity
CRP
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients showing intracranial, pulmonary or gastrointestinal hemorrhage.
2) Patients with serious hepatopathy such as fulminant hepatitis, uncompensated liver cirrhosis and others
3) Patients with a history of hypersensitivity to rTM.
4) Pregnant women, nursing mothers or possibly pregnant women.
Key exclusion criteria
1) Patients showing intracranial, pulmonary or gastrointestinal hemorrhage.
2) Patients with serious hepatopathy such as fulminant hepatitis, uncompensated liver cirrhosis and others
3) Patients with a history of hypersensitivity to rTM.
4) Pregnant women, nursing mothers or possibly pregnant women.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Shirasaka |
Organization
Kobe University Graduate School of Medicine, Kobe, Japan
Division name
Department of Surgery, Division of Cardiovascular Surgery
Zip code
Address
7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe, Hyogo
TEL
078-382-5942
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Shirasaka |
Organization
Kobe University Graduate School of Medicine, Kobe, Japan
Division name
Department of Surgery, Division of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Yutaka Okita
Institute
Department
Personal name
Funding Source
Organization
Asahi-Kasei Pharma
Organization
Division
Category of Funding Organization
Profit organization
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 | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recombinant human thrombomodulin is administrated to the patients for 6 days
after the definite diagnosis as DIC(380 unit/kg/day).
Blood clotting test findings (FDP, D dimer, TAT, PIC) is evaluated and DIC score is calculated after the treatment.
Management information
Registered date
| 2013 | Year | 05 | Month | 01 | Day |
Last modified on
| 2013 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012432
