UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of thrombomodulin-alpha on the systemic inflammation and the postoperative course among patients after open heart surgery for the congenital heart diseases.
Title of the study (Brief title)	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	Takeshi Yoshii
Organization	Gunma Children's Medical Center
Division name	Dept. of Cardiovascular Surgery
Address	779 Shimohakoda, Hokkitsumachi, Shibukawa-city, Gunma
TEL	0279-52-3551
Email	yosiit-tky@umin.net

Public contact
Name of contact person	Takeshi Yoshii
Organization	Gunma Children's Medical Center
Division name	Dept. of Cardiovascular Surgery
Address	779 Shimohakoda, Hokkitsumachi, Shibukawa-city, Gunma
TEL	0279-52-3551
Homepage URL
Email	yosiit-tky@umin.net

Sponsor
Institute	Gunma Children's Medical Center
Institute
Department

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

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016724