UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies on the effect of free radical scavenger Edaravone against postoperative hyper-perfusion syndrome after STA-MCA bypass surgery for adult moyamoya disease.
Title of the study (Brief title)	Studies on the effect of free radical scavenger Edaravone against postoperative hyper-perfusion syndrome after STA-MCA bypass surgery for adult moyamoya disease.
Region	Japan

Condition
Condition	moyamoya disease
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of the edaravone against hyper-perfusion syndrome occuring after revascularization surgery for adult moyamoya disease. Patients who were administered edaravone prospectively is compared with the historical control group.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of the hyper-perfusion syndrome within 7 days after the revasucularization surgery.
Key secondary outcomes	The incidence of asymptomatic hyper-perfusion on the cerebral blood flow image within 7 days after the revascularization surgery.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Administration of edaravone from preoperative to postoperative day 7.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients with moyamoya disease scheduled for revascularization surgery in Hokkaido University Hospital.
Key exclusion criteria	Patients with serum creatinine level is greater than 1.5mg/dL. Patients with a history of hypersensitivity to edaravone. Patients determined to be ineligible to doctor due to a problem with the general condition.
Target sample size	32

Research contact person
Name of lead principal investigator	Kiyohiro Houkin
Organization	Hokkaido University Hospital
Division name	Department of Neurosurgery
Address	North-15, West-7, Kita-ku, Sapporo, Japan
TEL	011-706-5987
Email	houkin@med.hokudai.ac.jp

Public contact
Name of contact person	Naoki Nakayama
Organization	Hokkaido University Hospital
Division name	Department of Neurosurgery
Address	North-15, West-7, Kita-ku, Sapporo, Japan
TEL	011-706-5987
Homepage URL
Email	naoki-na@med.hokudai.ac.jp

Sponsor
Institute	Department of Neurosurgery, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Neurosurgery, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 03 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date
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	2012 Year 08 Month 21 Day
Last modified on	2016 Year 10 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010267