Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
NCT ID: NCT05806346
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
764 participants
INTERVENTIONAL
2023-08-01
2025-06-30
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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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
TXA administration
Tranexamic acid intravenous administration
Placebo administration
Placebo (normal saline) intravenous administration
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
TXA administration
Tranexamic acid intravenous administration
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
TXA administration
Tranexamic acid intravenous administration
Placebo administration
Placebo (normal saline) intravenous administration
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
Placebo administration
Placebo (normal saline) intravenous administration
Interventions
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TXA administration
Tranexamic acid intravenous administration
Placebo administration
Placebo (normal saline) intravenous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients who provide written informed consent
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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Korea Health Industry Development Institute
OTHER_GOV
Helptrial
UNKNOWN
Asan Medical Center
OTHER
Samsung Medical Center
OTHER
Konkuk University Medical Center
OTHER
Responsible Party
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Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Principal Investigators
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Tae-Yop Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Konkuk University Medical Center
Locations
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Konkuk University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Chung-Sik Oh, MD, PhD
Role: primary
Jung Chan Park, MD
Role: primary
Jaesik Nam
Role: primary
References
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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.
Other Identifiers
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HI22C1952-1-3
Identifier Type: -
Identifier Source: org_study_id