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

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

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-10

Study Completion Date

2025-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthritis Knee Spine Fusion Prostate Cancer Arthritis of Hip Hepatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized prospective multicenter non-inferior

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TXA empirical

Empirical Tranexamic acid (TXA) administration after the anesthesia induction

Group Type ACTIVE_COMPARATOR

TXA

Intervention Type DRUG

Tranexamic acid injection 8-10mg/kg

TXA TEG6-triggered

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

Group Type EXPERIMENTAL

TXA

Intervention Type DRUG

Tranexamic acid injection 8-10mg/kg

TEG6

Intervention Type DIAGNOSTIC_TEST

performing thromboelastography (TEG6)

TXA TEG6-non-triggered

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

Group Type EXPERIMENTAL

TEG6

Intervention Type DIAGNOSTIC_TEST

performing thromboelastography (TEG6)

Interventions

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TXA

Tranexamic acid injection 8-10mg/kg

Intervention Type DRUG

TEG6

performing thromboelastography (TEG6)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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TXA administration thromboelastography 6

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes