UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017304 |
|---|---|
| Receipt number | R000019970 |
| Scientific Title | Exploratory research on the combination therapy of the endovascular thrombectomy and the local brain hypothermia in severe cerebral ischemia within internal carotid artery territory |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2016/03/04 18:13:52 |
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Basic information
Public title
Exploratory research on the combination therapy of the endovascular thrombectomy and the local brain hypothermia in severe cerebral ischemia within internal carotid artery territory
Acronym
COOL IVR study
Scientific Title
Exploratory research on the combination therapy of the endovascular thrombectomy and the local brain hypothermia in severe cerebral ischemia within internal carotid artery territory
Scientific Title:Acronym
COOL IVR study
Region
| Japan |
Condition
Condition
Cerebral infarction
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate the safety of the combination therapy of the endovascular thrombectomy and the local brain hypothermia in severe cerebral ischemia within 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 achievement degree of temperature lowering
2,The change of symptom
3,The infarction and edema formation in radiological findings
4,The physical findings and laboratory data
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
Local Brain hypothermia
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) tPA contra-indicated patients who can be treated with endovascular thrombetomy within 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 )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 with severely compressed ventricle due to brain edema.
10) Patients who are not suitable for the study in the opinion of the investigator.
Target sample size
6
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
houkin@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeo Abumiya |
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
abumiya@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 28 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019970
