UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016435 |
|---|---|
| Receipt number | 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 23:27:05 |
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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
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
hinolab2@yahoo.co.jp
Sponsor or person
Institute
SaiseikaiShigaken Hospital
department of neurosurgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019087
