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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016435
Receipt No. R000019087
Scientific Title Ultra-early emergency embolectomy for acute occlusion of the internal carotid artery and middle cerebral artery
Date of disclosure of the study information 2015/02/05
Last modified on 2015/02/03

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Basic information
Public title Ultra-early emergency embolectomy for acute occlusion of the internal carotid artery and middle cerebral artery
Acronym UEEEA
Scientific Title Ultra-early emergency embolectomy for acute occlusion of the internal carotid artery and middle cerebral artery
Scientific Title:Acronym UEEEA
Region
Japan

Condition
Condition acute occlusion of internal carotid artery and proximal middle cerebral artery
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Surgical embolectomy, first introduced in 1956, is still the most powerful treatment for achieving good recanalization. However, it is regarded as a relic since it requires a large surgical team and time-consuming steps, including anesthesia, craniotomy, and microsurgery. We establish seamless collaboration among all services involved, refine surgical techniques, and prospectively investigate the feasibility and safety of emergency surgical embolectomy and assess whether it deserves reappraisal in current acute stroke therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes recanalization and safety after operation
Key secondary outcomes neurological outcome at 90 days

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 surgical embolectomy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Surgical indications included the presence of acute hemispheric symptoms, absence of low-density area on computed tomography, evidence of internal carotid artery or proximal middle cerebral artery occlusion, and availability of resources to start surgery within 3 hours of symptom onset and National Institutes of Health Scale>10.
Key exclusion criteria Patients with rapidly improving symptom were excluded. Each patient's relatives provided informed consent. They were informed that systemic thrombolysis is currently the only therapy for acute stroke with proven efficacy according to large prospective randomized studies. if informed consent was not obtained, the patients were excluded.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Hino
Organization SaiseikaiShigaken Hospital
Division name department of neurosurgery
Zip code
Address Ohashi2-4-1 ritto, Shiga
TEL 077-552-1221
Email hinolab2@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Hino
Organization SaiseikaiShigaken Hospital
Division name department of neurosurgery
Zip code
Address Ohashi2-4-1 ritto, Shiga
TEL 077-552-1221
Homepage URL
Email hinolab2@yahoo.co.jp

Sponsor
Institute SaiseikaiShigaken Hospital
department of neurosurgery
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 05 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 Completed
Date of protocol fixation
2005 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2005 Year 02 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 03 Day
Last modified on
2015 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019087

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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