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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034824
Receipt No. R000039712
Official scientific title of the study Efficacy of intravenous tranexamic acid administration for Hybrid CWHTO :a randomized control trial
Date of disclosure of the study information 2018/11/10
Last modified on 2018/11/08

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Basic information
Official scientific title of the study Efficacy of intravenous tranexamic acid administration for Hybrid CWHTO :a randomized control trial
Title of the study (Brief title) Efficacy of intravenous tranexamic acid administration for Hybrid CWHTO :a randomized control trial
Region
Japan

Condition
Condition Osteoarthritis of the knee,avascular necrosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether intravenous tranexamic acid administration can reduce blood loss after Hybrid Closed wedge high tibial osteotomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The volume of perioperative blood loss measured using the calculated blood volume and change in hemoglobin from preoperative to postoperative day 3
Key secondary outcomes 1. The volume of perioperative blood loss measured using the calculated blood volume and change in hemoglobin from preoperative to postoperative day 7
2. Total postoperative drainage volume
3. Knee circumference at postoperative day 7
4. Complication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous tranexamic acid group:
Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 6 hours after the first intravenous administration of tranexamic acid.
Interventions/Control_2 Controll group:
No administration of tranexiamic acid
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 Patients undergoing unilateral Hybrid Closed wedge tibial osteotomy
Key exclusion criteria 1.Patients scheduled for Hybrid Closed wedge high tibial osteotomy combined with implant removal.
2.Patients who had allergy for tranexiamic acid
Target sample size 60

Research contact person
Name of lead principal investigator Takuya Iseki
Organization Hyogo College of Medicine
Division name Orthopaedic Surgery
Address Mukogawacho 1-1, Nishinomiya, Hyogo, Japan
TEL 0798456111
Email takuyaiseki@gmail.com

Public contact
Name of contact person Takuya Iseki
Organization Hyogo College of Medicine
Division name Orthopaedic Surgery
Address Mukogawacho 1-1, Nishinomiya, Hyogo, Japan
TEL 0798456111
Homepage URL
Email takuyaiseki@gmail.com

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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
2018 Year 11 Month 10 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 08 Day
Last modified on
2018 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039712

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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