UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014504 |
|---|---|
| Receipt number | R000016724 |
| Scientific Title | The effect of thrombomodulin-alpha on the systemic inflammation and the postoperative course among patients after open heart surgery for the congenital heart diseases. |
| Date of disclosure of the study information | 2014/07/08 |
| Last modified on | 2017/03/23 14:53:24 |
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Basic information
Public title
The effect of thrombomodulin-alpha on the systemic inflammation and the postoperative course among patients after open heart surgery for the congenital heart diseases.
Acronym
The induction of thrombomodulin-alpha for patients with open heart surgery for congenital heart diseases.
Scientific Title
The effect of thrombomodulin-alpha on the systemic inflammation and the postoperative course among patients after open heart surgery for the congenital heart diseases.
Scientific Title:Acronym
The induction of thrombomodulin-alpha for patients with open heart surgery for congenital heart diseases.
Region
| Japan |
Condition
Condition
Congenital heart diseases
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement of the systemic inflammation and the postoperative course.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse events
Key secondary outcomes
Clinical efficacy of the therapy in postoperative period.
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of thrombomodulin-alpha
Interventions/Control_2
Placebo
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
| 2 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants and neonates with congenital heart diseases who are scheduled to undergo open heart surgery with the aortic cross clamp over 1 hour.
Key exclusion criteria
Patients with chromosomal abnormalities.
Cases with other investigational medicine.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yoshii |
Organization
Gunma Children's Medical Center
Division name
Dept. of Cardiovascular Surgery
Zip code
Address
779 Shimohakoda, Hokkitsumachi, Shibukawa-city, Gunma
TEL
0279-52-3551
yosiit-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Yoshii |
Organization
Gunma Children's Medical Center
Division name
Dept. of Cardiovascular Surgery
Zip code
Address
779 Shimohakoda, Hokkitsumachi, Shibukawa-city, Gunma
TEL
0279-52-3551
Homepage URL
yosiit-tky@umin.net
Sponsor or person
Institute
Gunma Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Gunma Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Miyata Cardiac Research Promotion Foundation
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
群馬県立小児医療センター（群馬県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 08 | 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
| 2013 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 08 | Day |
Last modified on
| 2017 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016724
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