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| Name | Class |
|---|---|
| Korea Health Industry Development Institute | OTHER_GOV |
| Helptrial | UNKNOWN |
| Asan Medical Center | OTHER |
| Samsung Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TXA administration | Drug | Tranexamic acid intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative bleeding | bleeding amount though chest drainage tubes during the 1st postoperative 24 hour | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative transfusion amount | amounts of transfused red blood cells, plasma, platelet and cryoprecipitate | 24 hours |
| postoperative transfusion rate | incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae-Yop Kim, MD PhD | Contact | +82-10-8811-6942 | taeyop@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tae-Yop Kim, MD, PhD | Konkuk University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Recruiting | Seoul | 05030 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39334224 | Derived | 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. |
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| OTHER |
randomized prospective double-blind placebo-controlled multicenter non-inferior
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placebo-controlled
|
| Placebo administration | Drug | Placebo (normal saline) intravenous administration |
|
|
| 24 hours |
| the lowest postoperative hemoglobin value | the nadir hemoglobin value during one postoperative days | 24 hours |
| incidence of reoperation | incidence of reoperation due to postoperative bleeding | 1 week |
| amount of intraoperative cell salvage | amounts of infused salvaged blood | 1 hour |
| viscoelastic whole blood profile | values of intraoperative CT-EXTEM, CFT-EXTEM, A10-EXTEM, MCF-EXTEM, ML-EXTEM, CT-FIBTEM, CFT-FIBTEM, A10-FIBTEM, MCF-FIBTEM, ML-FIBTEM in rotational thromboelastometry | 1 hour |
| incidence of seizure | incidence of postoperative seizure till the hospital discharge | 1 week |
| incidence of thromboembolic complications | incidence of postoperative myocardia infarction, stroke, pulmonary embolism, gut infarction till the hospital discharge | 1 week |
| duration of mechanical ventilation | duration of postoperative ventilatory care | 1 week |
| length of stays in the ICU and hospital | duration of stay in the ICU and hospital | 1 week |
| total cost | total expense paid at the discharge | 2 week |
| incidence of taking renal replacement therapy | incidence of taking hemodylaysis | 1 week |
| incidence of acute kidney injury | diagnosed by KIDGO criteria | 1 week |
| incidence of postoperative delirium | delirium digested by CAM-ICU | 1 week |
| incidence of applying for mechanical circulatory support | incidences of applying IABP, ECMO, VAD | 1 week |
| in-hospital mortality | hospital death | 1 week |
| central laboratory blood tests | hemoglobin, platelet number, Prothrombin timeI activated partial thromboplastin timePTT , fibrinogen concentration, d-dimer | 1 week |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001778 | Blood Coagulation Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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