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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028871
Receipt No. R000033037
Scientific Title Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Date of disclosure of the study information 2017/08/29
Last modified on 2019/09/03

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Basic information
Public title Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Acronym Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Scientific Title Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Scientific Title:Acronym Effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Region
Japan

Condition
Condition osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effect of intraarticular tranexamic acid on reducing blood loss after arthroplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is total blood loss (postoperative day 1).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 After the skin incision was closed, tranexamic acid is infiltrated into the joint.
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

Not applicable
Gender Male and Female
Key inclusion criteria Ptients undergoing primary arthroplasty.
Key exclusion criteria Patients with allergy to tranexamic acid, preoperative renal dysfunction, deranged coagulation profile and history of thromboembolic disease.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Hasegawa
Organization Mie University Graduate School of Medicine
Division name Orthopaedic Surgery
Zip code 514-8507
Address 2-174 Edobashi Tsu Mie
TEL 0592321111
Email seikei@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Yohei
Middle name
Last name Naito
Organization Mie University Graduate School of Medicine
Division name Orthopaedic Surgery
Zip code 514-8507
Address 2-174 Edobashi Tsu Mie
TEL 0592321111
Homepage URL
Email seikei@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Self funding.
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 Mie University Hospital
Address 2-174 Edobashi Tsu Mie
Tel 0592321111
Email kk-sien@mo.medic.mie-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
2017 Year 08 Month 29 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 14 Day
Date of IRB
2016 Year 11 Month 24 Day
Anticipated trial start date
2016 Year 12 Month 15 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
2017 Year 08 Month 28 Day
Last modified on
2019 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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