UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039851 |
|---|---|
| Receipt number | R000045443 |
| Scientific Title | A multicenter randomized controlled trial on the efficacy of trans arterial cooling infusion with endovascular therapy for acute ischemic stroke |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2020/03/17 17:18:20 |
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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
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
kucchan-23@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045443
