UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter randomized controlled trial on the efficacy of trans arterial cooling infusion with endovascular therapy for acute ischemic stroke
Acronym	A multicenter randomized controlled trial on the efficacy of trans arterial cooling infusion with endovascular therapy for acute ischemic stroke
Scientific Title	A multicenter randomized controlled trial on the efficacy of trans arterial cooling infusion with endovascular therapy for acute ischemic stroke
Scientific Title:Acronym	A multicenter randomized controlled trial on the efficacy of trans arterial cooling infusion with endovascular therapy for acute ischemic stroke
Region	Japan

Condition
Condition	acute ischemic stroke
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We hypothesized that trans arterial cooling infusion would be effective for patients with ischemia/reperfusion injury. The aim of this study is to investigate efficacy and safety of this therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	modified Rankin scale 0-2 at 90 days after onset of acute ischemic stroke
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Just after recanalization, we infuse cool saline from guiding catheter to Internal Carotid Artery.
Interventions/Control_2	Just after recanalization, we infuse warm saline from guiding catheter to Internal Carotid Artery.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients are eligible to be included in this study, who are more than 18 years old, symptomatic (NIHSS more than 2), confirmed large vessel occlusion of anterior circulation (ICA, MCAM1-2), no large infarct (DWI-ASPECTS more than 5 ), can be punctured within 8 hours from onset, get recanalization (TICI grade more than 2a) and be taken informed consent.
Key exclusion criteria	Patients are excluded in this study, who are allergic to contrast agents, have a history of arterial puncture for which compression bleeding is difficult, have severe kidney damage, are latating and pregnant, whose life expectancy is expected to be within 90 days, and are judged inappropriate by doctor.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Kazumi Middle name Last name Kimura
Organization	Nippon Medical School Hospital
Division name	departmento of neurology
Zip code	113-8602
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Email	kucchan-23@nms.ac.jp

Public contact
Name of contact person	1st name Akihito Middle name Last name Kutsuna
Organization	Nippon Medical School Hospital
Division name	departmento of neurology
Zip code	113-8602
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Homepage URL
Email	kucchan-23@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	Nippon Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nippon Medical School Hospital
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel	03-3822-2131
Email	kucchan-23@nms.ac.jp

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	2020 Year 03 Month 18 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	Enrolling by invitation
Date of protocol fixation	2018 Year 08 Month 31 Day
Date of IRB	2018 Year 08 Month 31 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2022 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	2020 Year 03 Month 17 Day
Last modified on	2020 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045443