Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty

Konkuk University Medical Center

Status: Not yet enrolling

Conditions: Arthritis of Hip

Treatments: Drug: Placebo; Diagnostic Test: thromboelastography; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05956769

HI22C195200-1-2

Details and patient eligibility

About

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 vs Preemptive Tranexamic Acid Administration in total hip arthroplasty. 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion Criteria patients undergoing following surgery

• total hip arthroplasty

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: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 3 patient groups

Empirical 2: TXA administration

Active Comparator group

Description:

Tranexamic acid administration, regardless of the result of TEG6.

Treatment:

Diagnostic Test: thromboelastography

Drug: Tranexamic Acid

Goal-directed 1: Placebo administration

Experimental group

Description:

Normal saline administration, according to the result of TEG6. . Placebo administration, at LY30 \< 3% or MA \> 54 mm in CRT of TEG6

Treatment:

Diagnostic Test: thromboelastography

Drug: Placebo

Goal-directed 2: TXA administration

Experimental group

Description:

Tranexamic acid administration, according to the result of TEG6. Placebo discard, at LY30\> 3% or MA\<54 mm in CRT of TEG6

Treatment:

Diagnostic Test: thromboelastography

Drug: Tranexamic Acid