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

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 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


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

Value
https://center6.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