UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013662 |
|---|---|
| Receipt number | R000015942 |
| Scientific Title | Establishment of the strategic prophylaxis for the deep vein thrombosis by the remote ischemic preconditioning. |
| Date of disclosure of the study information | 2014/04/08 |
| Last modified on | 2019/10/11 20:42:54 |
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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
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
shaku@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University Hospital
Institute
Department
Personal name
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015942
