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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthritis of Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferior

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Empirical 2: TXA administration

Tranexamic acid administration, regardless of the result of TEG6.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr

thromboelastography

Intervention Type DIAGNOSTIC_TEST

thromboelastography (TEG6)

Goal-directed 1: Placebo administration

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

Group Type EXPERIMENTAL

thromboelastography

Intervention Type DIAGNOSTIC_TEST

thromboelastography (TEG6)

Placebo

Intervention Type DRUG

Normal saline injection

Goal-directed 2: TXA administration

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr

thromboelastography

Intervention Type DIAGNOSTIC_TEST

thromboelastography (TEG6)

Interventions

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Tranexamic Acid

Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr

Intervention Type DRUG

thromboelastography

thromboelastography (TEG6)

Intervention Type DIAGNOSTIC_TEST

Placebo

Normal saline injection

Intervention Type DRUG

Other Intervention Names

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Normal saline

Eligibility Criteria

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Inclusion Criteria

\- 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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes