UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009226 |
|---|---|
| Receipt number | R000010834 |
| Scientific Title | Examination of intraoperative use of tranexamic acid in patients undergoing radical hysterectomy |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2019/01/09 05:53:32 |
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Basic information
Public title
Examination of intraoperative use of tranexamic acid in patients undergoing radical hysterectomy
Acronym
Examination of intraoperative use of tranexamic acid in patients undergoing radical hysterectomy
Scientific Title
Examination of intraoperative use of tranexamic acid in patients undergoing radical hysterectomy
Scientific Title:Acronym
Examination of intraoperative use of tranexamic acid in patients undergoing radical hysterectomy
Region
| Japan |
Condition
Condition
uterine cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
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 radical hysterectomy
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
the rate of intraoperative transfusion,perioperative complication rate
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A loading dose of 500mg of tranexamic acid is infused slowly intravenously 20 minutes before surgery,and a continuous intravenous infusion of tranexamic acid is given at a rate of 250mg/h from surgical incision until skin closure.
Interventions/Control_2
A loading dose of 5ml of saline is infused slowly intravenously 20 minutes before surgery,and a continuous intravenous infusion of saline is given at a rate of 2.5ml/h from surgical incision until skin closure.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients older than 18 years old and undergoing radical hysterectomy(associated with lymph node dissection when required for oncological radicality) 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 | Takaya Hojo |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Anaesthesia
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaya Hojo |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Anaesthesia
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
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
Address
Tel
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
東京都立多摩総合医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 31 | Day |
Last modified on
| 2019 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010834
