UMIN-CTR Clinical Trial

Basic information
Public title	The effect of tranexamic acid on blood loss in bimaxillary orthognathic surgery.
Acronym	The effect of tranexamic acid on blood loss in bimaxillary orthognathic surgery.
Scientific Title	The effect of tranexamic acid on blood loss in bimaxillary orthognathic surgery.
Scientific Title:Acronym	The effect of tranexamic acid on blood loss in bimaxillary orthognathic surgery.
Region	Japan

Condition
Condition	Jaw defomities
Classification by specialty	Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the efficacy of intraoperative treatment with tranexamic acid in reducing intraoperative blood loss in patients undergoing orthognathic surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	intraoperative blood loss
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A loading dose of 20mg/kg of tranexamic acid in infused intravenously before Le Fort 1 osteotomy.
Interventions/Control_2	A loading dose of 10mg/kg of tranexamic acid in infused intravenously before Le Fort 1 osteotomy and sagittal splitting ramus osteotomy.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients older than 16 years old and undergoing orthognathic surgery agoreed to participate in this traial.
Key exclusion criteria	Exclusion criteria are atrial fibrillation, coronary artery disease treated with drug eluting stent, severe choronic renal failure, congenital or acquried thrombophillia, and known or suspected allergy to tranexamic acid.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Ichikawa
Organization	Tokyo Metroplitan Ohtsuka Hospital
Division name	Department of Stomatology
Zip code	170-8476
Address	2-8-1 Minami-ohtsuka,Toshima-ku,Tokyo
TEL	03-3941-3211
Email	hideki_ichikawa@tmhp.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Ichikawa
Organization	Tokyo Metropolitan Ohtsuka Hospital
Division name	Depertment of Stomatology
Zip code	170-8476
Address	2-8-1 Minami-ohtsuka,Toshima-ku,Tokyo
TEL	03-3941-3211
Homepage URL
Email	hideki_ichikawa@tmhp.jp

Sponsor
Institute	Tokyo Metropolitan Ohtsuka Hospital
Institute
Department

Funding Source
Organization	None
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	Tokyo Metropolitan Ohtsuka Hospital
Address	2-8-1 Minami-ohtsuka,Toshima-ku,Tokyo
Tel	03-3941-3211
Email	hideki_ichikawa@tmhp.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	東京都立大塚病院

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 01 Day

Related information
URL releasing protocol	https://doi.org/10.5927/jjjd.28.269
Publication of results	Partially published

Result
URL related to results and publications	https://doi.org/10.5927/jjjd.28.269
Number of participants that the trial has enrolled	99
Results	It has been suggested that TXA may be able to reduce intraoperative blood loss during orthognathic surgery.
Results date posted	2020 Year 12 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2018 Year 12 Month 25 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 26 Day
Date of IRB	2015 Year 08 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 01 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	2015 Year 06 Month 27 Day
Last modified on	2020 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020968