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

Sponsor

Konkuk University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05957822

Collaborator

Korea Health Industry Development Institute (Other), Asan Medical Center (Other), Soon Chun Hyang University (Other)

148

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 TXA administration in high-risk non-cardiac surgery. 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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis Knee Spine Fusion Prostate Cancer Arthritis of Hip Hepatic Cancer	Diagnostic Test: thromboelastography Drug: Tranexamic Acid Drug: Placebo	N/A

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 amounts of postoperative bleeding during postoperative 24 hours through chest tube drainage using two different tranexamic acid (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, 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 Design

Study Type:

Interventional

Anticipated Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized prospective double-blind placebo-controlled multicenter non-inferiorrandomized prospective double-blind placebo-controlled multicenter non-inferior

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Empirical 1: TXA and Placebo administration Tranexamic acid administration, regardless of the result of TEG6. Placebo administration, 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 Drug: Placebo 0.9% NaCl with a volume comparable to Tranexamic acid
Active Comparator: Empirical 2: TXA administration Tranexamic acid administration, regardless of 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
Experimental: Goal-directed 1: Placebo administration Tranexamic acid administration, regardless of the result of TEG6. Placebo administration, at LY30> 3% or MA<54 mm in CRT of TEG6	Diagnostic Test: thromboelastography thromboelastography (TEG6) Drug: Placebo 0.9% NaCl with a volume comparable to Tranexamic acid
Experimental: Goal-directed 2: TXA and Placebo administration Tranexamic acid administration, regardless of 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

Outcome Measures

Primary Outcome Measures

CRT maximal amplitude [24 hours]
maximal amplitude of CRT test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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