UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficiency of insulin-like growth factor 1 therapy for cerebral ischemia by cardiopulmonary arrest
Title of the study (Brief title)	Efficiency of IGF-1 therapy for cerebral ischemia by CPA
Region	Japan

Condition
Condition	Cerebral ischemia by cardiopulmonary arrest
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficiency of insulin-like growth factor 1 therapy for cerebral ischemia by cardiopulmonary arrest
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Inhospital mortality
Key secondary outcomes	Neurologic outcome

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	insulin-like growth factor 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	15 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	cardiopulmonary arrest
Key exclusion criteria	trauma
Target sample size	30

Research contact person
Name of lead principal investigator	Naoya Matsuda
Organization	Yokohama City Minato Red Cross Hospital
Division name	Emergency and critical care center
Address	3-12-1 Shinyamashita, Naka-ku, Yokohama city, Japan
TEL	045-628-6100
Email	n.matsuda.shinshu@gmail.com

Public contact
Name of contact person	Naoya Matsuda
Organization	Yokohama City Minato Red Cross Hospital
Division name	Emergency and critical care center
Address	3-12-1 Shinyamashita, Naka-ku, Yokohama city, Japan
TEL	045-628-6100
Homepage URL
Email	n.matsuda.shinshu@gmail.com

Sponsor
Institute	Emergency and critical care center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	TEIJIN Pharma
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	横浜市立みなと赤十字病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 05 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2016 Year 10 Month 01 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 05 Day
Last modified on	2016 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000021399