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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012288
Receipt No. R000014368
Scientific Title The effect of tranexamic acid on blood loss in orthognathic surgery.
Date of disclosure of the study information 2013/11/13
Last modified on 2015/06/12

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

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

Objectives
Narrative objectives1 To determine the efficacy of intraoperative treatment with low dose 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 10mg/kg of tranexamic acid is infused intravenously before surgery.
Interventions/Control_2 A loading dose of 5ml of saline is infused intravenously before surgery.
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 agreed to participate in this traial.
Key exclusion criteria Exclusion criteria are atrial fibrillation,coronary artery disease treated with drug eluting stent,severe chronic renal failure,congenital or acquired thrombophilia,and known or suspected allergy to tranexamic acid.
Target sample size 100

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

Public contact
Name of contact person
1st name
Middle name
Last name Aki Ito
Organization Tokyo Metropolitan Ohtsuka Hospital
Division name Department of Stomatology
Zip code
Address 2-8-1 Minami-ohtsuka,Toshima-ku,Tokyo
TEL 03-3941-3211
Homepage URL
Email ot_koukuu@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
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 東京都立大塚病院

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 13 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 Completed
Date of protocol fixation
2013 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 13 Day
Last modified on
2015 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014368

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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