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Recruitment status
Unique ID issued by UMIN UMIN000001840
Receipt No. R000002218
Scientific Title Intravascular thrombolysis after transvenous rtPA treatment in patients with acute major cerebral artery occlusion
Date of disclosure of the study information 2009/04/02
Last modified on 2009/04/02

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Basic information
Public title Intravascular thrombolysis after transvenous rtPA treatment in patients with acute major cerebral artery occlusion
Acronym Intravascular thrombolysis after i.v. rtPA for acute cerebral ischemia
Scientific Title Intravascular thrombolysis after transvenous rtPA treatment in patients with acute major cerebral artery occlusion
Scientific Title:Acronym Intravascular thrombolysis after i.v. rtPA for acute cerebral ischemia
Region
Japan

Condition
Condition Acute occlusion of the internal carotid artery
Acute occlusion of the middle cerebral artery
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to improve outcome of patients with acute major cerebral artery occlusion using combined transvenous and intravascular rtPA treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Complication of the procedure.
2) mRS at discharge.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intravascular surgery after iv rtPA
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Within 3 hours after onset of symptoms.
2) Severe hemiparesis and eye ball deviation.
Key exclusion criteria 1) Marked improvement of symptoms after iv rtPA.
2) Previous hemorrhagic disease.
3) Apparent and fresh lesion on CT.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Sorimachi
Organization Brain Research institute, University of Niigata
Division name Department of Neurosurgery
Zip code
Address 1-757, Asahimachidori, Chuoku, Niigata
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Brain Research Institute, University of Niigata
Division name Department of Neurosurgery
Zip code
Address
TEL 025-227-0651
Homepage URL
Email

Sponsor
Institute Department of Neurosurgery, Brain Research Institute, University of Niigata
Institute
Department

Funding Source
Organization Department of Neurosurgery, Brain Research Institute, University of Niigata
Organization
Division
Category of Funding Organization
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
2009 Year 04 Month 02 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
Date of protocol fixation
2009 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 02 Day
Last modified on
2009 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002218

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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