UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004871 |
|---|---|
| Receipt number | 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 19:43:42 |
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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
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
baken1976@yahoo.co.jp
Sponsor or person
Institute
Center Hospital of the National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005797
