UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039636 |
|---|---|
| Receipt number | R000045032 |
| Scientific Title | The effect of lower limb compression for prevention of deep vein thrombosis Examination by changes in venous blood flow velocity in lower limbs using ultrasonic Doppler method |
| Date of disclosure of the study information | 2020/02/28 |
| Last modified on | 2020/02/28 17:52:58 |
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Basic information
Public title
Verification of the effect of lower limb compression for prevention of deep vein thrombosis
Acronym
Verification of the effect of lower limb compression for prevention of deep vein thrombosis
Scientific Title
The effect of lower limb compression for prevention of deep vein thrombosis
Examination by changes in venous blood flow velocity in lower limbs using ultrasonic Doppler method
Scientific Title:Acronym
The effect of lower limb compression for prevention of deep vein thrombosis
Examination by changes in venous blood flow velocity in lower limbs using ultrasonic Doppler method
Region
| Japan |
Condition
Condition
Persons with no history of deep vein thrombosis
Classification by specialty
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of elastic stockings and intermittent air compression used to prevent the onset of deep vein thrombosis, using changes in lower limb venous blood flow velocity by ultrasonic Doppler method as an index. And get guidance on these more effective uses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in popliteal venous blood flow rate due to pressurization of the lower leg
Key secondary outcomes
1.Variation of popliteal bleeding velocity with degree and time of pressurization of lower leg
2.Changes in popliteal bleeding velocity after plantar flexion and dorsiflexion of the foot before and after wearing elastic stockings
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of lower limb venous blood flow velocity by ultrasonic Doppler method. Examination of the effect of wearing elastic stockings, examination on pressurization method of intermittent pneumatic compression.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy adult(20 years or older, under,70 years,both male and female)
2.Those who agree with the purpose of this test
3.Those who are 20 years old or older at the time of obtaining consent
4.Those who have given written consent by themselves after receiving sufficient explanation
5.Not hospitalized
Key exclusion criteria
1.History of deep vein thrombosis,those who are treating deep vein thrombosis
2.History of cerebral infarction,myocardial infarction
3.Taking anticoagulant medication
4.Inflammation or wound on lower leg skin
5.Others who are judged by the investigator to be inappropriate as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sachihiko |
| Middle name | |
| Last name | Nobuoka |
Organization
St. Marianna University School of Medicine
Division name
Department of Laboratory medicine
Zip code
216-8511
Address
2-16-1, sugao, miyamae, Kawasaki, Kanagawa
TEL
0449778111
s.-nobuoka@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | sachiko |
| Middle name | |
| Last name | tsuchida |
Organization
St. Marianna University School of Medicine
Division name
Department of Laboratory medicine
Zip code
216-8511
Address
2-16-1, sugao, miyamae, Kawasaki, Kanagawa
TEL
0449778111
Homepage URL
sachiokot@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
St. Marianna University School of Medicine
Address
2-16-1, sugao , miyamae, Kawasaki , Kanagawa
Tel
04497781114051
k-sienbu.mail@marianna-u.ac.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
| 2020 | Year | 02 | Month | 28 | 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
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
Preinitiation
Date of protocol fixation
| 2020 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045032
