UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013642 |
|---|---|
| Receipt number | 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 22:39:32 |
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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
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
ojimarionet999@hp-emerg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Traumatology and Acute Critical Medicine
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015923
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
