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

Konkuk University Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Arthritis of Hip; Hepatic Cancer; Arthritis Knee; Spine Fusion; Prostate Cancer

Treatments: Diagnostic Test: TEG6; Drug: TXA

Study type: Interventional

Funder types: Other

Identifiers

NCT05957822

HI22C195200-1-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 3 patient groups

TXA empirical

Active Comparator group

Description:

Empirical Tranexamic acid (TXA) administration after the anesthesia induction

Treatment:

Drug: TXA

TXA TEG6-triggered

Experimental group

Description:

When LY30≥3% or MA\<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered

Treatment:

Diagnostic Test: TEG6

Drug: TXA

TXA TEG6-non-triggered

Experimental group

Description:

When LY30\<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered

Treatment:

Diagnostic Test: TEG6