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

Email

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


Email

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


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)


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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name