UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003327 |
|---|---|
| Receipt number | 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 16:08:52 |
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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
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
t_horiuchi@seichokai.or.jp
Sponsor or person
Institute
Bellland General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003885
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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