Clinical trial NCT05957822: Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery
Official title: Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Arthritis Knee
Spine Fusion
Prostate Cancer
Arthritis of Hip
Hepatic Cancer
Keywords: bleeding
viscoelastic test
tranexamic acid
transfusion
thromboembolism
fibrinolysis
seizure
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
name: Asan Medical Center
name: Soon Chun Hyang University
First posted: 2023-07-24
Enrollment: 148
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized prospective multicenter non-inferior
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: CRT maximal amplitude
timeFrame: 24 hours
Secondary outcomes:
measure: CK reaction time
timeFrame: 24 hours
measure: CK alpha angle
timeFrame: 24 hours
measure: CRT maximal lysis
timeFrame: 24 hours
measure: CFF maximal amplitude
timeFrame: 24 hours
measure: Hemoglobin
timeFrame: 24 hours
measure: packed RBC
timeFrame: 6 hours
measure: fresh frozen plasma
timeFrame: 6 hours
measure: cryoprecipitate
timeFrame: 6 hours
measure: platelet
timeFrame: 6 hours
measure: seizure
timeFrame: 48 hours
measure: thromboembolism
timeFrame: 48 hours
measure: postoperative bleeding
timeFrame: 48 hours
measure: re-operation
timeFrame: 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Tae-Yop Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: