ClinicalTrials.gg
CompletedNCT05806346Updated Oct 27, 2026

Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

An interventional study of TXA administration and Placebo administration in Heart Diseases, Vascular Diseases and Transfusion Related Complication, sponsored by Konkuk University Medical Center. Completed at 3 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Konkuk University Medical Center · Not applicable, Interventional, and Diagnostic

Updated Oct 27, 2026Now CompletedFirst site in South Korea+6 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
764
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 31 studies in Heart Diseases with a site in Korea, Republic of — 8 open to participants now, 10 under way, 2 of them phase 3. Heart Diseases · Korea, Republic of.

Enrollment
11th of 23
764 · median 632
Started
2023
with 3 others
No phase
12 of 31
3 open now
Registered
23rd of 31
by date

Among the 31 studies in Heart Diseases with a site in Korea, Republic of, this one is the 11th largest by enrollment of the 23 interventional ones that give a count, is one of 4 that started in 2023, is one of 12 with no phase, and was the 23rd registered.

Heart Diseases

2,135 studies on the registry are indexed under Heart Diseases; 252 are open to participants now.

Browse Heart Diseases studies →

Open to participants now

8 of the 31 studies in Heart Diseases with a site in Korea, Republic of are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 181 Heart Diseases studies recruiting now, 128 (71%) set no upper age limit and 21 (12%) stop at 75 or younger; 32 take children under 18; 42 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial.

The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.

The secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures.

Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.

Read the detailed description

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial.

This study's primary objective is to compare the amounts of postoperative bleeding during postoperative 24 hours through chest tube drainage using two different tranexamic acid (TXA) administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.

The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, thromboembolic complications, and postoperative seizures.

Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.

03

Conditions studied

  • Heart Diseases
  • Vascular Diseases
  • Transfusion Related Complication
  • Coagulation Disorder, Blood
  • Fibrinolysis; Hemorrhage
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
  • patients who provide written

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • refusal of allogenic blood transfusion
  • taking thrombin
  • history of thromboembolic and familial hypercoagulability disease
  • recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
  • hypersensitive to TXA
  • histroy of convulsion or epilepsy
  • taking hemodialysis
  • history of Heparin-induced thrombocytopenia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
764 participants (actual)

Study arms

  • Active comparator
    Empirical 1: TXA and Placebo administration

    Tranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo administration, at LI60 \< 85 % or A10\< 40 mm in EXTEM of rotational thromboelastometry

    Drug: TXA administration · Drug: Placebo administration

  • Active comparator
    Empirical 2: TXA administration

    Tranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo discard, at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry

    Drug: TXA administration

  • Experimental
    Goal-directed 1: Placebo administration

    Placebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid administration at LI60 \< 85 % or A10 \< 40 mm in EXTEM of rotational thromboelastometry

    Drug: TXA administration · Drug: Placebo administration

  • Experimental
    Goal-directed 2: TXA and Placebo administration

    Placebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid discard at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry

    Drug: Placebo administration

Interventions

  • Tranexamic acid intravenous administration

    Also known as: Tranexamic acid

  • DrugPlacebo administration

    Placebo (normal saline) intravenous administration

    Also known as: Placebo (normal saline)

06

What researchers measure

Primary outcomes

  1. postoperative bleeding

    bleeding amount though chest drainage tubes during the 1st postoperative 24 hour

    Time frame: 24 hours

Secondary outcomes

  1. postoperative transfusion amount

    amounts of transfused red blood cells, plasma, platelet and cryoprecipitate

    Time frame: 24 hours

  2. postoperative transfusion rate

    incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions

    Time frame: 24 hours

  3. the lowest postoperative hemoglobin value

    the nadir hemoglobin value during one postoperative days

    Time frame: 24 hours

  4. incidence of reoperation

    incidence of reoperation due to postoperative bleeding

    Time frame: 1 week

  5. amount of intraoperative cell salvage

    amounts of infused salvaged blood

    Time frame: 1 hour

  6. viscoelastic whole blood profile

    values of intraoperative CT-EXTEM, CFT-EXTEM, A10-EXTEM, MCF-EXTEM, ML-EXTEM, LY30-EXTEM, CT-FIBTEM, CFT-FIBTEM, A10-FIBTEM, MCF-FIBTEM, ML-FIBTEM in rotational thromboelastometry

    Time frame: 1 hour

  7. incidence of seizure

    incidence of postoperative seizure till the hospital discharge

    Time frame: 1 week

  8. incidence of thromboembolic complications

    incidence of postoperative myocardia infarction, stroke, pulmonary embolism, gut infarction till the hospital discharge

    Time frame: 1 week

  9. duration of mechanical ventilation

    duration of postoperative ventilatory care

    Time frame: 1 week

  10. length of stays in the ICU and hospital

    duration of stay in the ICU and hospital

    Time frame: 1 week

  11. total cost

    total expense paid at the discharge

    Time frame: 2 week

  12. incidence of taking renal replacement therapy

    incidence of taking hemodylaysis

    Time frame: 1 week

  13. incidence of acute kidney injury

    diagnosed by KIDGO criteria

    Time frame: 1 week

  14. incidence of postoperative delirium

    delirium digested by CAM-ICU

    Time frame: 1 week

  15. incidence of applying for mechanical circulatory support

    incidences of applying IABP, ECMO, VAD

    Time frame: 1 week

  16. in-hospital mortality

    hospital death

    Time frame: 1 week

  17. central laboratory blood tests

    hemoglobin, platelet number, Prothrombin timeI activated partial thromboplastin timePTT , fibrinogen concentration, d-dimer

    Time frame: 1 week

  18. Days alive at home

    Counts days spent living at home during the first 30 and 90 postoperative days

    Time frame: 1 month

  19. Fibrinolysis phenotype

    Hyperfibrinolysis, physiologic fibrinolysis, fibrinolysis shutdown

    Time frame: 1 hour

07

Study locations

3 sites
  • Konkuk University Medical Center
    Seoul, Seoul 05030, South Korea
  • Samsung Medical Center
    Seoul, Seoul 06351, South Korea
  • Asan Medical Center
    Seoul, Seoul, South Korea
08

References and documents

Publications

  • Nam JS, Oh CS, Kim JY, Choi DK, Oh AR, Park J, Lee JH, Yun SC, Kim KW, Jang MU, Kim TY, Choi IC. A multi-center, double-blind, placebo-controlled, randomized, parallel-group, non-inferiority study to compare the efficacy of goal-directed tranexamic acid administration based on viscoelastic test versus preemptive tranexamic acid administration on postoperative bleeding in cardiovascular surgery (GDT trial). Trials. 2024 Sep 27;25(1):623. doi: 10.1186/s13063-024-08467-1. PubMed 39334224 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2023 to primary completion in Oct 2026, 38 months.

Of 263 non-industry interventional studies with no phase under Heart Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's 38 months is above that.

Counting every sponsor, half of 336 studies reached it within 25 months; a quarter within 10 and three quarters within 52.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Apr 2025 → Oct 2026 and completion Jun 2025 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2023
First posted
Apr 10, 2023
StartActual
Aug 1, 2023
Primary completionActual
Oct 10, 2026was Apr 2025
CompletionActual
Oct 23, 2026was Jun 2025
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 27, 2026
Sites
3 sites added, 3 sites removed — first site in South Korea; no longer in Korea, Republic of
Show 3 added (3 South Korea)
  • Konkuk University Medical Center · Seoul, South Korea
  • Samsung Medical Center · Seoul, South Korea
  • Asan Medical Center · Seoul, South Korea
Show 3 removed
  • Konkuk University Medical Center · Seoul, Korea, Republic of
  • Samsung Medical Center · Seoul, Korea, Republic of
  • Asan Medical Center · Seoul, Korea, Republic of
Oct 27, 2026
Primary completion
Apr 30, 2025→Oct 10, 2026 (actual)
Oct 27, 2026
Study completion
Jun 30, 2025→Oct 23, 2026 (actual)
Oct 27, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 39334224 ↗
Oct 27, 2026
Secondary outcomes
2 added, 1 description edited
What changed in the outcomes
  • AddedDays alive at homeTime frame: 1 month
  • AddedFibrinolysis phenotypeTime frame: 1 hour
  • Descriptionviscoelastic whole blood profile: how it is measured was reworded
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Recruiting→Completed
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 39334224 ↗
    3 sites added, 3 sites removed — first site in South Korea; no longer in Korea, Republic of
    Show 3 added (3 South Korea)
    • Konkuk University Medical Center · Seoul, South Korea
    • Samsung Medical Center · Seoul, South Korea
    • Asan Medical Center · Seoul, South Korea
    Show 3 removed
    • Konkuk University Medical Center · Seoul, Korea, Republic of
    • Samsung Medical Center · Seoul, Korea, Republic of
    • Asan Medical Center · Seoul, Korea, Republic of
    Primary completion Apr 30, 2025→Oct 10, 2026 (now actual)
    Study completion Jun 30, 2025→Oct 23, 2026 (now actual)
    Secondary outcomes 2 added, 1 description edited
    What changed in the outcomes
    • AddedDays alive at homeTime frame: 1 month
    • AddedFibrinolysis phenotypeTime frame: 1 hour
    • Descriptionviscoelastic whole blood profile: how it is measured was reworded
    + 3 other changes: verification date, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05806346
Lead sponsor
Konkuk University Medical Center
Collaborators
Korea Health Industry Development Institute, Helptrial, Asan Medical Center, Samsung Medical Center
Responsible party
Tae-Yop Kim, MD PhD (Professor of Anesthesiology, Konkuk University Medical Center) — Principal investigator
First posted
Apr 10, 2023
Start date
Aug 1, 2023
Primary completion
Oct 10, 2026
Completion
Oct 23, 2026
Last update
Oct 27, 2026

Study contacts

Tae-Yop Kim, MD, PhD
principal investigator · Konkuk University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Tranexamic Acid

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