UMIN-CTR Clinical Trial

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
Email	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
Email	sachiokot@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045032