UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective observational study of blood culture collection in patients with accidental hypothermia
Acronym	Aroha study
Scientific Title	A retrospective observational study of blood culture collection in patients with accidental hypothermia
Scientific Title:Acronym	Aroha study
Region	Japan

Condition
Condition	Hypothermia
Classification by specialty	Medicine in general Infectious disease Laboratory medicine Emergency medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the significance of blood culture collection in patients with hypothermia and investigate factors related to treatment of hypothermia and prognosis.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood culture results and time, true blood culture positive rate, contamination rate
Key secondary outcomes	Patient background (including age, gender, primary disease), diagnosis, body temperature at first treatment, antibiotics, culture tests, blood counts / biochemical tests / coagulation tests / immunological tests, death and outcome

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who visited the National Center for Global Health and Medicine emergency department from January 1, 2012 to April 31, 2019 and received treatment for hypothermia.
Key exclusion criteria	Cases with missing values in the subject background information item
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tatsuki Middle name Last name Uemura
Organization	National Center for Global Health and Medicine
Division name	Emergency department
Zip code	162-8655
Address	1-21-1, Toyama,Shinjuku-ku,Tokyo, Japan
TEL	03-3202-7181
Email	tuemura@hosp.ncgm.go.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Kawashima
Organization	National Center for Global Health and Medicine
Division name	Emergency department
Zip code	162-8655
Address	1-21-1, Toyama,Shinjuku-ku,Tokyo, Japan
TEL	03-3202-7181
Homepage URL
Email	akawashima@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Global Health and Medicine
Address	1-21-1, Toyama,Shinjuku-ku,Tokyo, Japan
Tel	03-3202-7181
Email	akawashima@hosp.ncgm.go.jp

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	2019 Year 10 Month 11 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	200
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	2012 Year 01 Month 01 Day
Date of IRB	2019 Year 12 Month 09 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is for adults over the age of 20. Patients who visited our emergency department from January 1, 2012 to April 31, 2019 and received treatment for hypothermia.

Management information
Registered date	2019 Year 10 Month 10 Day
Last modified on	2021 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043620