UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of intravenous administration of tranexamic acid in curved periacetabular osteotomy
Title of the study (Brief title)	The efficacy of intravenous administration of tranexamic acid in curved periacetabular osteotomy
Region	Japan

Condition
Condition	acetabular dysplasia
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the evidence for the efficacy of tranexamic acid in reducing blood loss after curve periacetabular osteotomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total Blood loss
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous tranexamic acid 1000mg at the time of incision
Interventions/Control_2	Intravenous tranexamic acid 1000mg at the time of incision and 1000mg at the time of closure
Interventions/Control_3	control subjects
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	acetabular dysplasia over twenty years of age
Key exclusion criteria	A history of VTE , renal dysfunction, use of hormone replacement therapy
Target sample size	120

Research contact person
Name of lead principal investigator	Ayumi Matsunaga
Organization	Fukuoka University
Division name	Dept.of Orthop.Surg
Address	7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL	092-801-1011
Email	matsunaga_s580930@yahoo.co.jp

Public contact
Name of contact person	Ayumi Matsunaga
Organization	Fukuoka University
Division name	Dept.of Orthop.Surg
Address	7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL	092-801-1011
Homepage URL
Email	matsunaga_s580930@yahoo.co.jp

Sponsor
Institute	Fukuoka University,Dept.of Orthop.Surg
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	2016 Year 07 Month 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 10 Day
Anticipated trial start date	2016 Year 07 Month 17 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	2016 Year 07 Month 06 Day
Last modified on	2016 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026555