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Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05957822
Enrollment
148
Registered
2023-07-24
Start date
2024-02-10
Completion date
2025-01-01
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis Knee, Arthritis of Hip, Hepatic Cancer, Prostate Cancer, Spine Fusion

Keywords

bleeding, viscoelastic test, tranexamic acid, transfusion, thromboembolism, fibrinolysis, seizure

Brief summary

The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, 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 coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in non-cardiac surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, during postoperative 2bleeding, 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

Tranexamic acid injection 8-10mg/kg

DIAGNOSTIC_TESTTEG6

performing thromboelastography (TEG6)

Sponsors

Korea Health Industry Development Institute
CollaboratorOTHER_GOV
Asan Medical Center
CollaboratorOTHER
Soon Chun Hyang University
CollaboratorOTHER
Konkuk University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

randomized prospective multicenter non-inferior

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

patients undergoing following surgery * spinal fusion surgery with more than 2 levels * total hip arthroplasty * total knee arthroplasty * open prostatectomy * hepatectomy

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

MeasureTime frameDescription
CRT maximal amplitude24 hoursmaximal amplitude of CRT test

Secondary

MeasureTime frameDescription
re-operation48 hoursincidence of re-operation due to postoperative bleeding
CK reaction time24 hoursvalue of r-time of CK test
CK alpha angle24 hoursvalue of alpha-angle of CK test
CRT maximal lysis24 hoursvalue of maximal lysis of CRT test
CFF maximal amplitude24 hoursvalue of maximal amplitude of CFF test
Hemoglobin24 hoursserum hemoglobin value
postoperative bleeding48 hoursamount of bleeding from surgical drain
fresh frozen plasma6 hoursnumber of unit, transfused fresh frozen plasma
cryoprecipitate6 hoursnumber of unit, transfused cryoprecipitate
platelet6 hoursnumber of unit, transfused platelet (apheresis) or platelet concentrate
seizure48 hoursincidence of postoperative seizure
thromboembolism48 hoursincidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
packed RBC6 hoursnumber of unit, transfused packed RBC

Countries

South Korea

Contacts

Primary ContactTae-Yop Kim
taeyop@gmail.com+82 10 8811 6942
Backup ContactWooseul Lee
wslee.kku@gmail.com+82 10 8805 5661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026