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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009226
Receipt No. 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

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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
Obsterics 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
Email

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
Email

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010834

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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