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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | emergency patients with prolonged immobility | ||
Classification by specialty |
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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 |
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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. | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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, |
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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 |
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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 |
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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 | |
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 |
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IRB Contact (For public release) | |
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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 |
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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 |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | 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 | |
Registered date | File name |
Research case data | |
Registered date | File name |