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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035022
Receipt No. R000039936
Scientific Title Influence of prehospital delay and facility capability on the clinical outcomes of acute ischemic stroke
Date of disclosure of the study information 2018/11/28
Last modified on 2018/11/27

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Basic information
Public title Influence of prehospital delay and facility capability on the clinical outcomes of acute ischemic stroke
Acronym J-ASPECT transport
Scientific Title Influence of prehospital delay and facility capability on the clinical outcomes of acute ischemic stroke
Scientific Title:Acronym J-ASPECT transport
Region
Japan

Condition
Condition Stroke
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Emergency medical services (EMS) and inpatient stroke databases and sought to examine whether total EMS transport time and facility capability of stroke care are associated with outcomes in patients with Acute Ischemic Stroke.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 30 day mortality after the hospitalaization for stroke and modified Rankin Scale 0-2
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria We identified patients hospitalized for stroke in a deidentified discharge database using the International Classification of Diseases (ICD)10 diagnosis codes related to ischemic stroke (I63 0to9), nontraumatic intracerebral haemorrhage (ICH I61 0 to9) and subarachnoid haemorrhage (SAH I60 0to9). Because of major differences in their typical prognosis, patients with transient ischemic attack were excluded. We further selected those patients who had been urgently admitted between 1 April 2013 and 31 March 2015 to the hospitals.
Key exclusion criteria Non emergent cases
Target sample size 53858

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Iihara
Organization Kyushu University, Graduate School of Medical Sciences
Division name Department of Neurosurgery
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL +81-92-642-5521
Email kiihara@ns.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Iihara
Organization Kyushu University, Graduate School of Medical Sciences
Division name Department of Neurosurgery
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL +81-92-642-5521
Homepage URL https://j-aspect.jp/
Email kiihara@ns.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 11 Month 28 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 No longer recruiting
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A total of 53,858 patients with AIS were included in the final analyses. For all groups, a higher CSC score was associated with decreased mortality (e.g. the MT group, each one-point increase odds ratio, [95% confidence interval]: 0.826 [0.768-0.887]), and more favorable outcomes for all but the MT group. For all groups, longer total EMS response time was associated with decrease in favorable outcomes (e.g. the MT group, each one-minute increase: 0.989 [0.979-0.998]), but not with mortality. For all groups, a significant proportion of patients arrived at hospitals with CSC capabilities lower and later than the thresholds.

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039936

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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