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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018255
Receipt No. R000021101
Scientific Title an exploratory study of the brief local brain hypothermia in combination with endovascular thrombectomy for patients with t-PA refractory cerebral ischemia in internal carotid artery territory
Date of disclosure of the study information 2015/07/10
Last modified on 2017/02/21

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Basic information
Public title an exploratory study of the brief local brain hypothermia in combination with endovascular thrombectomy for patients with t-PA refractory cerebral ischemia in internal carotid artery territory
Acronym tPA COOL IVR study
Scientific Title an exploratory study of the brief local brain hypothermia in combination with endovascular thrombectomy for patients with t-PA refractory cerebral ischemia in internal carotid artery territory
Scientific Title:Acronym tPA COOL IVR study
Region
Japan

Condition
Condition Cerebral infarction
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the aim of this study is to estimate the safety of the brief local brain hypothermia for the patients with t-PA refractory cerebral ishcemia in internal carotid artery territory.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes The safety
Key secondary outcomes 1.The assessment of controlling the symptom after re-perfusion injury.
2.The assessment of infarction and cerebral edema due to images
3.the assessment of physical findings and clinical examination

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
Maneuver
Interventions/Control_1 Brief Local Brain hyporhermia
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients who are able to be treated with endovascular embolectomy after intravenous tPA in 8 hours from the onset.
2) Patients who needs endovascular thrombetomy because of severe cerebral ischemia by occlusion of the main trunk in internal carotid artery system.
3) Patients with symptom (NIHSS>=5)after recanalization.
4)Written informed consent provided by the patient or his/her family member.
Key exclusion criteria 1) Patients who cannot be submitted to angiography due to severe iodine allergy.
2) Patients with very light symptoms or quick improvement.
3) Patients with hemorrhagic lesions.
4) Patients with severe hepatic or renal disorder.
5) Patients with multiorgan failure or DIC due to cancer.
6) Patients with uncotrolled hypertention (systolic>185mmHg, diastoric >110mmHg).
7) Patients with uncotrolled glucose levels (<50 mg/dl, >400 mg/dl).
8) Patients with platelet count <100,000 /mm3.
9) Patients who are not suitable for the study in the opinion of the investigator.
Target sample size 7

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyohiro Houkin
Organization Hokkaido University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address North 15 West 7, Kita, Sapporo 060-8638, Japan
TEL 011-706-5987
Email houkin@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiya Osanai
Organization Hokkaido University Hospital
Division name Department of Neurosurgery
Zip code
Address North 14 West 5, Kita, Sapporo 060-8648, Japan
TEL 011-706-5987
Homepage URL
Email osanait@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Department of Neurosurgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道大学病院(北海道)
小樽市立病院(北海道)
北海道脳神経外科記念病院(北海道)
柏葉脳神経外科病院(北海道)
千歳市民病院(北海道)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 10 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 Open public recruiting
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 10 Day
Last follow-up date
2017 Year 07 Month 10 Day
Date of closure to data entry
2017 Year 07 Month 10 Day
Date trial data considered complete
2018 Year 01 Month 01 Day
Date analysis concluded
2018 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 09 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021101

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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