Heart DiseasesNCT05806346
Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
A study testing TXA administration in people with Heart Diseases and Vascular Diseases, run by Konkuk University Medical Center at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Diseases, Vascular Diseases, Transfusion Related Complication
- What is being tested?
- TXA administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 764 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 1 Aug 2023to 23 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
- patients who provide written informed consent
Who cannot join
- 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
Show all 9Show fewer
- histroy of convulsion or epilepsy
- taking hemodialysis
- history of Heparin-induced thrombocytopenia
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Konkuk University Medical Center
Seoul, Seoul, 05030
Samsung Medical Center
Seoul, Seoul, 06351
Asan Medical Center
Seoul, Seoul
About this study
Official title: Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration
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.
Read more
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.
- Conditions
- Heart Diseases, Vascular Diseases, Transfusion Related Complication, Coagulation Disorder, Blood, Fibrinolysis; Hemorrhage
- Being tested
- TXA administration, Placebo administration
- Medical subject headings
- Heart Diseases, Vascular Diseases, Blood Coagulation Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TXA administrationDrug
Also called Tranexamic acid
Tranexamic acid intravenous administration
Placebo administrationDrug
Also called Placebo (normal saline)
Placebo (normal saline) intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Empirical 1: TXA and Placebo administration | Active comparator | Tranexamic acid administration, regardless of the result of rotational thromboelastometry.
Placebo administration, at LI60 < 85 % or A10< 40 mm in EXTEM of rotational thromboelastometry Receives: Drug: TXA administration; Drug: Placebo administration |
| Empirical 2: TXA administration | Active comparator | Tranexamic acid administration, regardless of the result of rotational thromboelastometry.
Placebo discard, at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry Receives: Drug: TXA administration |
| Goal-directed 1: Placebo administration | Experimental | Placebo administration, regardless of the result of rotational thromboelastometry.
Tranexamic acid administration at LI60 < 85 % or A10 < 40 mm in EXTEM of rotational thromboelastometry Receives: Drug: TXA administration; Drug: Placebo administration |
| Goal-directed 2: TXA and Placebo administration | Experimental | Placebo administration, regardless of the result of rotational thromboelastometry.
Tranexamic acid discard at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry Receives: Drug: Placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative bleeding
bleeding amount though chest drainage tubes during the 1st postoperative 24 hour
Measured: 24 hours
Secondary outcomes (19)
postoperative transfusion amount
amounts of transfused red blood cells, plasma, platelet and cryoprecipitate
Measured: 24 hours
postoperative transfusion rate
incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions
Measured: 24 hours
the lowest postoperative hemoglobin value
the nadir hemoglobin value during one postoperative days
Measured: 24 hours
incidence of reoperation
incidence of reoperation due to postoperative bleeding
Measured: 1 week
amount of intraoperative cell salvage
amounts of infused salvaged blood
Measured: 1 hour
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
Measured: 1 hour
incidence of seizure
incidence of postoperative seizure till the hospital discharge
Measured: 1 week
incidence of thromboembolic complications
incidence of postoperative myocardia infarction, stroke, pulmonary embolism, gut infarction till the hospital discharge
Measured: 1 week
duration of mechanical ventilation
duration of postoperative ventilatory care
Measured: 1 week
length of stays in the ICU and hospital
duration of stay in the ICU and hospital
Measured: 1 week
total cost
total expense paid at the discharge
Measured: 2 week
incidence of taking renal replacement therapy
incidence of taking hemodylaysis
Measured: 1 week
incidence of acute kidney injury
diagnosed by KIDGO criteria
Measured: 1 week
incidence of postoperative delirium
delirium digested by CAM-ICU
Measured: 1 week
incidence of applying for mechanical circulatory support
incidences of applying IABP, ECMO, VAD
Measured: 1 week
in-hospital mortality
hospital death
Measured: 1 week
central laboratory blood tests
hemoglobin, platelet number, Prothrombin timeI activated partial thromboplastin timePTT , fibrinogen concentration, d-dimer
Measured: 1 week
Days alive at home
Counts days spent living at home during the first 30 and 90 postoperative days
Measured: 1 month
Fibrinolysis phenotype
Hyperfibrinolysis, physiologic fibrinolysis, fibrinolysis shutdown
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Aug 2023
- Primary completion10 Oct 2026
- Study completion23 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized prospective double-blind placebo-controlled multicenter non-inferior
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Helptrial, Asan Medical Center, Samsung Medical Center
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
- Investigators
- Tae-Yop Kim, MD, PhD, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806346
- Sponsor's protocol ID
- HI22C1952-1-3
- Status last verified
- Oct 2026
- First submitted
- 28 Mar 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration
- ClinicalTrials.gov ID
- NCT05806346
- Acronym / sponsor ID
- HI22C1952-1-3
- Conditions
- Heart Diseases, Vascular Diseases, Transfusion Related Complication, Coagulation Disorder, Blood, Fibrinolysis; Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Helptrial, Asan Medical Center, Samsung Medical Center
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 10 Oct 2026 (actual)
- Study completion
- 23 Oct 2026 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized prospective double-blind placebo-controlled multicenter non-inferior
| Arm | Type | Receives |
|---|---|---|
| Empirical 1: TXA and Placebo administration | Active comparator | Drug: TXA administration, Drug: Placebo administrationTranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo administration, at LI60 < 85 % or A10< 40 mm in EXTEM of rotational thromboelastometry |
| Empirical 2: TXA administration | Active comparator | Drug: TXA administrationTranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo discard, at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry |
| Goal-directed 1: Placebo administration | Experimental | Drug: TXA administration, Drug: Placebo administrationPlacebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid administration at LI60 < 85 % or A10 < 40 mm in EXTEM of rotational thromboelastometry |
| Goal-directed 2: TXA and Placebo administration | Experimental | Drug: Placebo administrationPlacebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid discard at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
- patients who provide written informed consent
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TXA administrationAlso: Tranexamic acidTranexamic acid intravenous administration | Drug | Empirical 1: TXA and Placebo administration, Empirical 2: TXA administration, Goal-directed 1: Placebo administration |
| Placebo administrationAlso: Placebo (normal saline)Placebo (normal saline) intravenous administration | Drug | Empirical 1: TXA and Placebo administration, Goal-directed 1: Placebo administration, Goal-directed 2: TXA and Placebo administration |
Primary outcome
postoperative bleeding
Time frame: 24 hours
bleeding amount though chest drainage tubes during the 1st postoperative 24 hour
19 secondary outcomes
postoperative transfusion amount
Time frame: 24 hours
postoperative transfusion rate
Time frame: 24 hours
the lowest postoperative hemoglobin value
Time frame: 24 hours
incidence of reoperation
Time frame: 1 week
amount of intraoperative cell salvage
Time frame: 1 hour
viscoelastic whole blood profile
Time frame: 1 hour
incidence of seizure
Time frame: 1 week
incidence of thromboembolic complications
Time frame: 1 week
duration of mechanical ventilation
Time frame: 1 week
length of stays in the ICU and hospital
Time frame: 1 week
total cost
Time frame: 2 week
incidence of taking renal replacement therapy
Time frame: 1 week
incidence of acute kidney injury
Time frame: 1 week
incidence of postoperative delirium
Time frame: 1 week
incidence of applying for mechanical circulatory support
Time frame: 1 week
in-hospital mortality
Time frame: 1 week
central laboratory blood tests
Time frame: 1 week
Days alive at home
Time frame: 1 month
Fibrinolysis phenotype
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Derived from this study: PubMed 39334224Nam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Yop Kim, MD, PhD principal investigator
Konkuk University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TXA administration in people with Heart Diseases and Vascular Diseases, run by Konkuk University Medical Center at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative bleeding (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05806346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.