UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018115 |
|---|---|
| Receipt number | R000020968 |
| Scientific Title | The effect of tranexamic acid on blood loss in bimaxillary orthognathic surgery. |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2020/12/25 17:51:36 |
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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
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
hideki_ichikawa@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Ohtsuka Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020968
