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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003327
Receipt No. R000003885
Scientific Title Search for optimum dose and timing of tranexamic acid administration in cardiac surgery with cardiopulmonary bypass.
Date of disclosure of the study information 2010/03/13
Last modified on 2013/03/19

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Basic information
Public title Search for optimum dose and timing of tranexamic acid administration in cardiac surgery with cardiopulmonary bypass.
Acronym Search for optimum dose and timing of tranexamic acid administration in cardiac surgery with cardiopulmonary bypass.
Scientific Title Search for optimum dose and timing of tranexamic acid administration in cardiac surgery with cardiopulmonary bypass.
Scientific Title:Acronym Search for optimum dose and timing of tranexamic acid administration in cardiac surgery with cardiopulmonary bypass.
Region
Japan

Condition
Condition cardiac insufficiency requiring surgery (for the patients undergoing cardiac surgery with cardiopulmonary bypass)
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is investigating the effects of relatively low dose of tranexamic acid on postoperative bleeding and other secondary outcomes in cardiac surgery with cardiopulmonary bypass.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes blood loss in 24 hours after surgery
Key secondary outcomes intraoperative blood loss
intraoperative transfusion
blood loss in 6 hours after surgery
blood loss in 12 hours after surgery
total blood loss after surgery
transfusion after surgery
hemostatic variavles before and after culdiopulmonary bypass
cytokines before and after culdiopulmonary bypass
postoperative complications
duration of mechanical ventilation
duration of intensive care unit stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group of NORMAL DOSE BEFORE CPB
a)30mg/kg b)16mg/kg/h c)2mg/kg d)NS

(CPB: cardiopulmonary bypass, NS: normal saline)

a) loading dose before CPB
b) maintenance dose after loading (5 hours)
c) priming dose in CPB circuit
d) dose after CPB and protamine administration
Interventions/Control_2 Group of LOWER DOSE BEFORE CPB
a)8mg/kg b)4mg/kg/h c)0.6mg/kg d)NS

(CPB: cardiopulmonary bypass, NS: normal saline)

a) loading dose before CPB
b) maintenance dose after loading (5 hours)
c) priming dose in CPB circuit
d) dose after CPB and protamine administration
Interventions/Control_3 Group of AFTER CPB
a)NS b)NS c)NS d)2g

(CPB: cardiopulmonary bypass, NS: normal saline)

a) loading dose before CPB
b) maintenance dose after loading (5 hours)
c) priming dose in CPB circuit
d) dose after CPB and protamine administration
Interventions/Control_4 Control group
a)NS b)NS c)NS d)2NS

(CPB: cardiopulmonary bypass, NS: normal saline)

a) loading dose before CPB
b) maintenance dose after loading (5 hours)
c) priming dose in CPB circuit
d) dose after CPB and protamine administration
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 surgey (coronary artery bypass graft or valvular replacement) with normothermic cardiopulmonary bypass.
Key exclusion criteria urgent/emergency operation, sepsis, infectious endocarditis, using IABP, renal insufficiency (Cre>2.0), active hepatitis, platerets<50000, preoperative hemostatic abnormality, continuous anticoagulant therapy, therapy with self blood, therapy with thrombin, allergy with taranexamic acid, patients recognised as inadequate for the study.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Horiuchi
Organization Bellland General Hospital
Division name Department of Anesthesia
Zip code
Address 500-3 Higashiyama, Naka-ku, Sakai, Osaka, 599-8247, Japan
TEL 072-234-2001
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshinori Horiuchi
Organization Bellland General Hospital
Division name Department of Anesthesia
Zip code
Address 500-3 Higashiyama, Naka-ku, Sakai, Osaka, 599-8247, Japan
TEL 072-234-2001
Homepage URL http://www.seichokai.or.jp/bell/chiken01.php
Email t_horiuchi@seichokai.or.jp

Sponsor
Institute Bellland General Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Daiichi-Sankyo Company

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 ベルランド総合病院(大阪府)
天理よろづ相談所病院(奈良県)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 13 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
2009 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
2012 Year 08 Month 01 Day
Date analysis concluded
2012 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 13 Day
Last modified on
2013 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003885

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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