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

Comparison of TEG-guided and Preemptive Tranexamic Acid Administration Strategies in Total Hip Replacement Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arthritis of Hip
• Intervention / Treatment: Diagnostic test: thromboelastography; Drug: Placebo; Drug: Tranexamic Acid

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of
    • Soi Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Empirical 2: TXA administration; Tranexamic acid administration, regardless of the result of TEG6.	Diagnostic test: thromboelastography; thromboelastography (TEG6); Drug: Tranexamic Acid; Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr
Experimental: 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	Diagnostic test: thromboelastography; thromboelastography (TEG6); Drug: Placebo; Normal saline injection; Other Names: Normal saline
Experimental: 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	Diagnostic test: thromboelastography; thromboelastography (TEG6); Drug: Tranexamic Acid; Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRT maximal amplitude	maximal amplitude of CRT test	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CK reaction time	r-time of CRT test	24 hours
CK alpha angle	alpha angle of CRT test	24 hours
CRT maximal lysis	maximal lysis of CRT test	24 hours
CFF maximal amplitude	maximal amplitude of CFF test	24 hours
Hemoglobin	the lowest hemoglobin value before transfusion	6 hours
packed RBC	transfused fresh frozen plasma	6 hours
fresh frozen plasma	transfused fresh frozen plasma	6 hours
cryoprecipitate	transfused cryoprecipitate	6 hours
platelet	transfused platelet (apheresis) or platelet concentrate	6 hours
seizure	postoperative incidence of seizure	48 hours
thromboembolism	preoperative incidence of myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction	48 hours
postoperative bleeding	bleeding from surgical drain	48 hours
re-operation	re-operation due to postoperative bleeding	48 hours
intraoperative bleeding	amount of intraoperative bleeding	4 hours

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 2, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: HI22C195200-1-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No