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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013642
Receipt No. R000015923
Scientific Title The study of the effect of electrical muscle stimulation on the prevention of deep vein thrombosis in emergency patients with prolonged immobility:randomised cotorolled trial.
Date of disclosure of the study information 2014/04/04
Last modified on 2017/03/28

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Basic information
Public title The study of the effect of electrical muscle stimulation on the prevention of deep vein thrombosis in emergency patients with prolonged immobility:randomised cotorolled trial.
Acronym The study of the effect of electrical muscle stimulation on the prevention of deep vein thrombosis.
Scientific Title The study of the effect of electrical muscle stimulation on the prevention of deep vein thrombosis in emergency patients with prolonged immobility:randomised cotorolled trial.
Scientific Title:Acronym The study of the effect of electrical muscle stimulation on the prevention of deep vein thrombosis.
Region
Japan

Condition
Condition emergency patients with prolonged immobility
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine the hypothesis of whether there is an additional effect of DVT by electrical muscle stimulation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes The velocities and volume of Pop.V and CFV during EMS and at rest.
Key secondary outcomes The change of D-dimer,FDP,CI,CO,etc.
The length of ICU stay.
The length of days with ventilator.
Prognosis after 28 days.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Electrical muscle stimulation(EMS) group:EMS is provided every day with usual prophylaxis for DVT.
Interventions/Control_2 Control group:usual prophylaxis only.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Critically patients requiring mechanical ventilation for more than a week.
Patients with lower limb paralysis due to head injury, stroke and spinal cord injury,
Key exclusion criteria Patients with lower limb burn.Pregnants.Pediatrics under 16.Patients with neurological history.Patients with pacemakeror or life-support electric equipment.Patients with SAH,epilepsy,congestive heart failure or unstable patients.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuo Onishi
Organization Osaka University Graduate School of Medicine
Division name Department of Traumatology and Acute Critical Medicine
Zip code
Address 2-15 Yamadaoka Suita,Osaka,Japan
TEL 06-6879-5707
Email mohnishi@hp-emerg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Ojima
Organization Osaka University Graduate School of Medicine
Division name Department of Traumatology and Acute Critical Medicine
Zip code
Address 2-15 Yamadaoka Suita,Osaka,Japan
TEL 06-6879-5707
Homepage URL
Email ojimarionet999@hp-emerg.med.osaka-u.ac.jp

Sponsor
Institute Department of Traumatology and Acute Critical Medicine
Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization National Mutual Insureance Federation of Agricultural Cooperatives
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://jintensivecare.biomedcentral.com/articles/10.1186/s40560-016-0206-8
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
2014 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 04 Day
Last follow-up date
2015 Year 05 Month 31 Day
Date of closure to data entry
2015 Year 05 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 26 Day
Date analysis concluded
2016 Year 12 Month 26 Day

Other
Other related information

Management information
Registered date
2014 Year 04 Month 04 Day
Last modified on
2017 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015923

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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