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

Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Hepatic Cancer; Spine Fusion; Arthritis Knee; Arthritis of Hip
• Intervention / Treatment: Diagnostic test: TEG6; Drug: TXA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tae-Yop Kim; Phone Number: +82 10 8811 6942; Email: taeyop@gmail.com
• Study Contact Backup: Name: Wooseul Lee; Phone Number: +82 10 8805 5661; Email: wslee.kku@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • Recruiting
    • Konkuk University Medical Center
    • Principal Investigator: Tae-Yop Kim, MD PhD
    • Contact: Tae-yop Kim, M.D, PhD; Email: taeyop@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria patients undergoing following surgery

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TXA empirical; Empirical Tranexamic acid (TXA) administration after the anesthesia induction	Drug: TXA; Tranexamic acid injection 8-10mg/kg; Other Names: TXA administration
Experimental: TXA TEG6-triggered; When LY30≥3% or MA<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered	Diagnostic test: TEG6; performing thromboelastography (TEG6); Other Names: thromboelastography 6; Drug: TXA; Tranexamic acid injection 8-10mg/kg; Other Names: TXA administration
Experimental: TXA TEG6-non-triggered; When LY30<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered	Diagnostic test: TEG6; performing thromboelastography (TEG6); Other Names: thromboelastography 6

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	value of r-time of CK test	24 hours
CK alpha angle	value of alpha-angle of CK test	24 hours
CRT maximal lysis	value of maximal lysis of CRT test	24 hours
CFF maximal amplitude	value of maximal amplitude of CFF test	24 hours
Hemoglobin	serum hemoglobin value	24 hours
packed RBC	number of unit, transfused packed RBC	6 hours
fresh frozen plasma	number of unit, transfused fresh frozen plasma	6 hours
cryoprecipitate	number of unit, transfused cryoprecipitate	6 hours
platelet	number of unit, transfused platelet (apheresis) or platelet concentrate	6 hours
seizure	incidence of postoperative seizure	48 hours
thromboembolism	incidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction	48 hours
postoperative bleeding	amount of bleeding from surgical drain	48 hours
re-operation	incidence of re-operation due to postoperative bleeding	48 hours

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Collaborators: Asan Medical Center; Korea Health Industry Development Institute; Soon Chun Hyang University
• Investigators: Principal Investigator: Tae-Yop Kim, MD, PhD, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 16, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: bleeding; thromboembolism; transfusion; tranexamic acid; seizure; fibrinolysis; viscoelastic test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Joint Diseases; Musculoskeletal Diseases; Arthritis; Liver Neoplasms; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: HI22C195200-1-1

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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