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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009883
Receipt No. 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

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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
Institute Nagasaki univesity Hospital
Institute
Department

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
URL(English) https://upload.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


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