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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004871
Receipt No. R000005797
Scientific Title Development of clinical decision rule to exclude subarachnoid hemorrhage (SAH) for acute headache
Date of disclosure of the study information 2011/01/16
Last modified on 2015/07/09

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Basic information
Public title Development of clinical decision rule to exclude subarachnoid hemorrhage (SAH) for acute headache
Acronym EMERALD SAH Rule
Scientific Title Development of clinical decision rule to exclude subarachnoid hemorrhage (SAH) for acute headache
Scientific Title:Acronym EMERALD SAH Rule
Region
Japan

Condition
Condition Patients with acute headache
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify numerical predidtors suggestive of SAH and develop a clinical decision rule that would help prevent misdiagnosis of SAH in patients with acute headache.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Presence of subarachnoid hemorrhage in patient with acute headache
The primary outcome: SAH is defined as any of the following: SAH on unenhanced computed tomography (CT) of the head; xanthochromia in cerebrospinal fluid; or bloody cerebrospinal fluid in the final tube sample at lumbar puncture.
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
15 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria adult patients with a chief complaint of acute headache
Key exclusion criteria 1) patients with headache caused by trauma, drugs or alcohol
2) patients who are unconscious at the beginning of assessment
3) patients with recurrent headache syndromes
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Kimura
Organization Center Hospital of the National Center for Global Health and Medicine
Division name Emergency medicine
Zip code
Address 1-21-1Toyama Shinjuku-ku Tokyo japan
TEL 03-3202-7181
Email akimura@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Kobayashi
Organization Center Hospital of the National Center for Global Health and Medicine
Division name Emergency medicine
Zip code
Address 1-21-1Toyama Shinjuku-ku Tokyo japan
TEL 03-3202-7181
Homepage URL
Email baken1976@yahoo.co.jp

Sponsor
Institute Center Hospital of the National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization .
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 国立国際医療研究センター病院(東京都)、大垣市民病院(岐阜県)、熊本医療センター(熊本県)、横須賀市立うわまち病院(神奈川県)、岐阜県総合医療センター(岐阜県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 16 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
2008 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 13 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
2014 Year 09 Month 30 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information Assessment and Data Collection
All patient assessments will be made by residents supervised by staff physicians or attending emergency physicians. Physicians will be oriented to the study and instructed to input clinical and laboratory findings at the time of assessment into data collection software specially developed on a smartphone, or onto electronic charts of a hospital that shows the same data items as the smartphone device. Electronic chart data will be later transferred to the smartphone device manually.
Data management
All patient data will be anonymized before being uploaded to the internet server via direct smartphone connection or from personal computers at emergency centers with Bluetooth connections to smartphone devices. Collected anonymized data will be monitored and cleaned by the Joint Center for Researchers, Associates and Clinicians (JCRAC), an authorized center for quality management of data. The final data set for analyses will be provided by JCRAC.
According to the methodological standards, we will conduct univariate analyses for the strength of association between each possible predictor variable and the outcome variables, and for selections of possible predictors. We will use multivariate, recursive partitioning analysis to develop the clinical decision rules using those possible predictors and the outcome. Sensitivity and specificity will be estimated for each rule. A clinical decision rule for a life-threatening event like SAH requires 100% sensitivity with a narrow confidence interval.


Management information
Registered date
2011 Year 01 Month 13 Day
Last modified on
2015 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005797

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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