UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of the strategic prophylaxis for the deep vein thrombosis by the remote ischemic preconditioning.
Acronym	A single blind parallel group randomized trial about the efficacy and safety of the remote ischemic preconditioning for the development of deep vein thrombosis during total knee arthroplasty using the tourniquet.
Scientific Title	Establishment of the strategic prophylaxis for the deep vein thrombosis by the remote ischemic preconditioning.
Scientific Title:Acronym	A single blind parallel group randomized trial about the efficacy and safety of the remote ischemic preconditioning for the development of deep vein thrombosis during total knee arthroplasty using the tourniquet.
Region	Japan

Condition
Condition	deep vein thrombosis
Classification by specialty	Vascular surgery Orthopedics Anesthesiology Laboratory medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of the remote ischemic preconditioning on the development of deep vein thrombosis during knee arthroplasty using the tourniquet.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Soluble fibrin monomer complex level D-Dimer level FDP level Plasminogen activity level
Key secondary outcomes	NF-kappa B level Plasma cytocine level (IL6, IL-1beta, IL-10, TNF-alpha) Safety (measured by incidence of adverse events and discontinuation rate due to adverse events)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Remote ischemic preconditioning induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff.
Interventions/Control_2	Control group: Without remote ischemic preconditioning.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing unilateral total knee arthroplasty using the tourniquet. Written informed consent.
Key exclusion criteria	Anticoagulant therapy Heparin bridge Neuropathy of the superior limb Brachial edema RA Steroid therapy Ischemic heart disease Obesity BMI>30
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kiyoshi Shakunaga
Organization	Toyama University Hospital
Division name	Surgical Center
Zip code
Address	2630 Sugitani, Toyama 930-0194 Japan
TEL	076-434-7377
Email	shaku@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kiyoshi Shakunaga
Organization	Toyama University Hospital
Division name	Surgical Center
Zip code
Address	2630 Sugitani, Toyama 930-0194 Japan
TEL	076-434-7377
Homepage URL
Email	shaku@med.u-toyama.ac.jp

Sponsor
Institute	Toyama University Hospital
Institute
Department

Funding Source
Organization	The Ministry of Education, Science, Sports and Culture
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
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Tel
Email

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	富山大学　附属病院

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 08 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	Completed
Date of protocol fixation	2011 Year 10 Month 18 Day
Date of IRB	2011 Year 10 Month 18 Day
Anticipated trial start date	2012 Year 02 Month 29 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 04 Month 07 Day
Last modified on	2019 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015942