UMIN-ICDS Clinical Trial

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

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

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

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.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

ardyanwardhana@staff.ubaya.ac.id

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

Email

ardyanwardhana@staff.ubaya.ac.id

Institute

Faculty of Medicine, Universitas Surabaya

Institute

Department

Personal name

Organization

Faculty of Medicine, Universitas Surabaya

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Universitas surabaya

Address

Jl. Raya Kalirungkut

Tel

6282138433032

Email

ardyanwardhana@staff.ubaya.ac.id

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

06

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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/icdr_e/ctr_view.cgi?recptno=R000058619