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

NCT05957822 | Recruiting Phase 4 DMC

• 1 other identifier: HI22C195200-1-1
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis Knee; Spine Fusion; Prostate Cancer; Arthritis of Hip; Hepatic Cancer

Keywords

bleeding; viscoelastic test; tranexamic acid; transfusion; thromboembolism; fibrinolysis; seizure

Outcome Measures

Primary Outcomes (1)

• CRT maximal amplitude

  maximal amplitude of CRT test

  24 hours

Secondary Outcomes (13)

• CK reaction time

  24 hours

• CK alpha angle

  24 hours

• CRT maximal lysis

  24 hours

• CFF maximal amplitude

  24 hours

• Hemoglobin

  24 hours

Study Arms (3)

TXA empirical

ACTIVE COMPARATOR

Empirical Tranexamic acid (TXA) administration after the anesthesia induction

Drug: TXA

TXA TEG6-triggered

EXPERIMENTAL

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

Drug: TXA; Diagnostic Test: TEG6

TXA TEG6-non-triggered

EXPERIMENTAL

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

Diagnostic Test: TEG6

Interventions

TXA DRUG

Tranexamic acid injection 8-10mg/kg

Also known as: TXA administration

TXA TEG6-triggered; TXA empirical

TEG6 DIAGNOSTIC_TEST

performing thromboelastography (TEG6)

Also known as: thromboelastography 6

TXA TEG6-non-triggered; TXA TEG6-triggered

Eligibility Criteria

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

You may qualify if:

• spinal fusion surgery with more than 2 levels
• total hip arthroplasty
• total knee arthroplasty
• open prostatectomy
• hepatectomy

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
• Korea Health Industry Development Institute: collaborator
• Asan Medical Center: collaborator
• Soon Chun Hyang University: collaborator

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Liver Neoplasms; Hemorrhage; Thromboembolism; Seizures

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Tae-Yop Kim, MD, PhD

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae-Yop Kim

CONTACT

+82 10 8811 6942; taeyop@gmail.com

Wooseul Lee

CONTACT

+82 10 8805 5661; wslee.kku@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: randomized prospective multicenter non-inferior

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 24, 2023
• Study Start: February 10, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)