UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of intravenous tranexamic acid administration for Hybrid CWHTO :a randomized control trial
Acronym	Efficacy of intravenous tranexamic acid administration for Hybrid CWHTO :a randomized control trial
Scientific Title	Efficacy of intravenous tranexamic acid administration for Hybrid CWHTO :a randomized control trial
Scientific Title:Acronym	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
Last name of lead principal investigator	1st name Middle name Last name Takuya Iseki
Organization	Hyogo College of Medicine
Division name	Orthopaedic Surgery
Zip code
Address	Mukogawacho 1-1, Nishinomiya, Hyogo, Japan
TEL	0798456111
Email	takuyaiseki@gmail.com

Public contact
1st name of contact person	1st name Middle name Last name Takuya Iseki
Organization	Hyogo College of Medicine
Division name	Orthopaedic Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
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

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 10 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	2018 Year 11 Month 01 Day
Date of IRB	2019 Year 02 Month 26 Day
Anticipated trial start date	2019 Year 02 Month 26 Day
Last follow-up date	2020 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 08 Day
Last modified on	2019 Year 05 Month 16 Day

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