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

NCT05956769 | Unknown DMC

• 1 other identifier: HI22C195200-1-2
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Arthritis of Hip

Outcome Measures

Primary Outcomes (1)

• CRT maximal amplitude

  maximal amplitude of CRT test

  24 hours

Secondary Outcomes (14)

• CK reaction time

  24 hours

• CK alpha angle

  24 hours

• CRT maximal lysis

  24 hours

• CFF maximal amplitude

  24 hours

• Hemoglobin

  6 hours

Study Arms (3)

Empirical 2: TXA administration

ACTIVE COMPARATOR

Tranexamic acid administration, regardless of the result of TEG6.

Drug: Tranexamic Acid; Diagnostic Test: thromboelastography

Goal-directed 1: Placebo administration

EXPERIMENTAL

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

Diagnostic Test: thromboelastography; Drug: Placebo

Goal-directed 2: TXA administration

EXPERIMENTAL

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

Drug: Tranexamic Acid; Diagnostic Test: thromboelastography

Interventions

Tranexamic Acid DRUG

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

Empirical 2: TXA administration; Goal-directed 2: TXA administration

thromboelastography DIAGNOSTIC_TEST

thromboelastography (TEG6)

Empirical 2: TXA administration; Goal-directed 1: Placebo administration; Goal-directed 2: TXA administration

Placebo DRUG

Normal saline injection

Also known as: Normal saline

Goal-directed 1: Placebo administration

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- total hip arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (2)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

Soi Lee

Seoul, South Korea

Location

MeSH Terms

Interventions

Tranexamic Acid; Thrombelastography; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

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

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 21, 2023
• Study Start: February 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

KR (2)