UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009883
Receipt number R000009527
Scientific Title Adjustment of blood coagulation for cardiopulmonary bypass surgery: Optimal dosage of tranexamic acid using thromboelastometry
Date of disclosure of the study information 2013/01/28
Last modified on 2019/08/29 13:55:41

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Basic information

Public title

Adjustment of blood coagulation for cardiopulmonary bypass surgery: Optimal dosage of tranexamic acid using thromboelastometry

Acronym

Optimal dosage of tranexamic acid for cardiopulmonary bypass surgery

Scientific Title

Adjustment of blood coagulation for cardiopulmonary bypass surgery: Optimal dosage of tranexamic acid using thromboelastometry

Scientific Title:Acronym

Optimal dosage of tranexamic acid for cardiopulmonary bypass surgery

Region

Japan


Condition

Condition

patients undergoig cardiac surgery with cardiopulmonary bypass

Classification by specialty

Vascular surgery Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate dose of tranexamic acid which reduse perioperative blood loss and/or is uneffective for postoperative seizures activity in patients undergoing cardiac surgery with cardiopulmonary bypass

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

perioperative blood loss, perioperative fibrinolytic system, ICU stay, postoperative seizure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

loding dose of tranexamic acid 12.5mg/kg,contnuous dose 6.5mg/kg/hr, extracorporealcirculation circuit dose 1mg/kg

Interventions/Control_2

loding dose of tranexamic acid 21mg/kg,contnuous dose 11mg/kg/hr, extracorporealcirculation circuit dose 1.5mg/kg

Interventions/Control_3

loding dose of tranexamic acid 30mg/kg,contnuous dose 16mg/kg/hr, extracorporealcirculation circuit dose 2mg/kg

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients undergoing cardiac surgery using extracorporeal circulation
(a written informed consent was obtained from each participant),first coronary artery bypass grafting/mitral valve plasty/mitral valve replacement/aortic valve replacement

Key exclusion criteria

renal dysfunction

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sungsam Cho

Organization

Nagasaki University Hospital

Division name

Anesthesiology

Zip code


Address

1-7-1,sakamoto,nagasaki city,nagasaki

TEL

095-819-7370

Email

chos@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sungsam Cho

Organization

Nagasaki University Hospital

Division name

Anesthesiology

Zip code


Address

1-7-1,sakamoto,nagasaki city,nagasaki

TEL

095-819-7370

Homepage URL


Email

chos@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki univesity Hospital

Institute

Department

Personal name



Funding Source

Organization

Anaesthesiology

Organization

Division

Category of Funding Organization

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



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 28 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

2012 Year 07 Month 01 Day

Date of IRB

2012 Year 06 Month 08 Day

Anticipated trial start date

2012 Year 07 Month 01 Day

Last follow-up date

2014 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 28 Day

Last modified on

2019 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009527


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name