UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051380 |
|---|---|
| Receipt number | R000058619 |
| Scientific Title | Efficacy and safety profile of low-dose tranexamic acid regimen in cardiac surgery: A meta-analysis |
| Date of disclosure of the study information | 2023/06/19 |
| Last modified on | 2023/06/19 15:28:32 |
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Basic information
Public title
Low-dose tranexamic acid regimen in cardiac surgery
Acronym
Low-dose tranexamic acid regimen in cardiac surgery
Scientific Title
Efficacy and safety profile of low-dose tranexamic acid regimen in cardiac surgery: A meta-analysis
Scientific Title:Acronym
Low-dose tranexamic acid regimen in cardiac surgery
Region
| Asia(except Japan) |
Condition
Condition
all randomized trials examining the bleeding-reducing effect of tranexamic acid in open-heart surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess the efficacy and safety profile of low-dose regimens in open-heart surgery compared to placebo and high-dose regimens
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this meta-analysis was safety issues, namely the level of adverse events, including mortality, bleeding-associated re-surgery, myocardial infarction, venous thromboembolic events (VTE), stroke, and seizures.
Key secondary outcomes
Secondary outcomes included efficacy issues in the form of the amount of bleeding in 24 h, the number of PRC unit transfusions in 24 h, intensive care unit (ICU) stay, and length of hospital stay.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
all randomized trials examining the bleeding-reducing effect of tranexamic acid in open-heart surgery based
Key exclusion criteria
We excluded studies that did not have the outcomes we wanted and those that did not have comparisons between low-dose regimens and placebo or high-dose regimens.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ardyan |
| Middle name | Prima |
| Last name | Wardhana |
Organization
Universitas Surabaya
Division name
Faculty of Medicine
Zip code
60293
Address
Jl. Raya Kalirungkut
TEL
6282138433032
ardyanwardhana@staff.ubaya.ac.id
Public contact
Name of contact person
| 1st name | Ardyan |
| Middle name | Prima |
| Last name | Wardhana |
Organization
Universitas surabaya
Division name
Faculty of Medicine
Zip code
60293
Address
Jl. Raya Kalirungkut
TEL
6282138433032
Homepage URL
ardyanwardhana@staff.ubaya.ac.id
Sponsor or person
Institute
Faculty of Medicine, Universitas Surabaya
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Universitas Surabaya
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
Universitas surabaya
Address
Jl. Raya Kalirungkut
Tel
6282138433032
ardyanwardhana@staff.ubaya.ac.id
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
| 2023 | Year | 06 | Month | 19 | 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
76
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
| 2023 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We reported this meta-analysis based on the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement. Three databases, including PUBMED, Clarivate Web of Science, and CENTRAL, were systematically searched using the search strategy shown in Supplementary file 1. Then, two authors conducted independent screening of all randomized trials examining the bleeding-reducing effect of tranexamic acid in open-heart surgery based on the inclusion criteria. Open-heart surgery includes coronary artery bypass graft (CABG) on or off pump, valve surgery, aortic surgery, or a combination of elective and emergency surgery. All included studies were searched for full text and then extracted data, including the type of surgery, number of participant populations, the average age of participants, sex percentage, randomization and blinding methods, criteria for packed-red cells (PRC) transfusion, and data according to the intended outcomes. We excluded studies that did not have the outcomes we wanted and those that did not have comparisons between low-dose regimens and placebo or high-dose regimens.
We compared pooled data for the low-dose vs. placebo and low-dose vs. high-dose groups. The boundary between the low-dose and high-dose groups was the regimen used in the BART study (bolus 30 mg/kg followed by 16 mg/kg/h intraoperatively, with a further 2 mg/kg added to the priming solution).[3] Administering a 30 mg/kg bolus or 2.5 g more than once is considered a high-dose regimen.
Management information
Registered date
| 2023 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058619
