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

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 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


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

Value
https://center6.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