UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Mitsuo Onishi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Traumatology and Acute Critical Medicine
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	Masahiro Ojima
Organization	Osaka University Graduate School of Medicine
Division name	Department of Traumatology and Acute Critical Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://jintensivecare.biomedcentral.com/articles/10.1186/s40560-016-0206-8
Results
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