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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05806346
Other study ID # HI22C1952-1-3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date December 31, 2024

Study information

Verified date December 2023
Source Konkuk University Medical Center
Contact Soi Lee
Phone +82 10 4418 9288
Email soileekku@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 764
Est. completion date December 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Intervention

Drug:
TXA administration
Tranexamic acid intravenous administration
Placebo administration
Placebo (normal saline) intravenous administration

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (5)

Lead Sponsor Collaborator
Konkuk University Medical Center Asan Medical Center, Helptrial, Korea Health Industry Development Institute, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative bleeding bleeding amount though chest drainage tubes during the 1st postoperative 24 hour 24 hours
Secondary postoperative transfusion amount amounts of transfused red blood cells, plasma, platelet and cryoprecipitate 24 hours
Secondary postoperative transfusion rate incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions 24 hours
Secondary the lowest postoperative hemoglobin value the nadir hemoglobin value during one postoperative days 24 hours
Secondary incidence of reoperation incidence of reoperation due to postoperative bleeding 1 week
Secondary amount of intraoperative cell salvage amounts of infused salvaged blood 1 hour
Secondary 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
Secondary incidence of seizure incidence of postoperative seizure till the hospital discharge 1 week
Secondary incidence of thromboembolic complications incidence of postoperative myocardia infarction, stroke, pulmonary embolism, gut infarction till the hospital discharge 1 week
Secondary duration of mechanical ventilation duration of postoperative ventilatory care 1 week
Secondary length of stays in the ICU and hospital 1 week
Secondary total cost total expense paid at the discharge 2 week
Secondary incidence of taking renal replacement therapy 1 week
Secondary incidence of acute kidney injury diagnosed by KIDGO criteria 1 week
Secondary incidence of postoperative delirium delirium digested by CAM-ICU 1 week
Secondary incidence of applying for mechanical circulatory support incidences of applying IABP, ECMO, VAD 1 week
Secondary in-hospital mortality 1 week
Secondary central laboratory blood tests hemoglobin, platelet number, Prothrombin timeI activated partial thromboplastin timePTT , fibrinogen concentration, d-dimer 1 week
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