Coagulation Disorder, Blood, Fibrinolysis; Hemorrhage, Heart Diseases, Transfusion Related Complication, Vascular Diseases
Conditions
Brief 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.
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.
Interventions
DRUGTXA administration
Tranexamic acid intravenous administration
DRUGPlacebo administration
Placebo (normal saline) intravenous administration
Sponsors
Korea Health Industry Development Institute
Helptrial
Asan Medical Center
Samsung Medical Center
Konkuk University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
placebo-controlled
Intervention model description
randomized prospective double-blind placebo-controlled multicenter non-inferior
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass * patients who provide written informed consent
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative bleeding | 24 hours | bleeding amount though chest drainage tubes during the 1st postoperative 24 hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| in-hospital mortality | 1 week | hospital death |
| incidence of acute kidney injury | 1 week | diagnosed by KIDGO criteria |
| incidence of postoperative delirium | 1 week | delirium digested by CAM-ICU |
| postoperative transfusion amount | 24 hours | amounts of transfused red blood cells, plasma, platelet and cryoprecipitate |
| postoperative transfusion rate | 24 hours | incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions |
| the lowest postoperative hemoglobin value | 24 hours | the nadir hemoglobin value during one postoperative days |
| incidence of reoperation | 1 week | incidence of reoperation due to postoperative bleeding |
| amount of intraoperative cell salvage | 1 hour | amounts of infused salvaged blood |
| incidence of applying for mechanical circulatory support | 1 week | incidences of applying IABP, ECMO, VAD |
| incidence of seizure | 1 week | incidence of postoperative seizure till the hospital discharge |
| incidence of thromboembolic complications | 1 week | incidence of postoperative myocardia infarction, stroke, pulmonary embolism, gut infarction till the hospital discharge |
| duration of mechanical ventilation | 1 week | duration of postoperative ventilatory care |
| length of stays in the ICU and hospital | 1 week | duration of stay in the ICU and hospital |
| total cost | 2 week | total expense paid at the discharge |
| incidence of taking renal replacement therapy | 1 week | incidence of taking hemodylaysis |
| central laboratory blood tests | 1 week | hemoglobin, platelet number, Prothrombin timeI activated partial thromboplastin timePTT , fibrinogen concentration, d-dimer |
| viscoelastic whole blood profile | 1 hour | 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 |
Countries
South Korea
Contacts
Primary ContactTae-Yop Kim, MD PhD
Outcome results
None listed