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

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 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


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

Value
https://center6.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