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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05957822
• Other study ID #: HI22C195200-1-1
• Status: Recruiting
• Phase: Phase 4
• Start date: February 10, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Konkuk University Medical Center
• Contact: Tae-Yop Kim
• Phone: +82 10 8811 6942
• Email: taeyop[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee
• Arthritis of Hip
• Hepatic Cancer
• Liver Neoplasms
• Prostate Cancer
• Spine Fusion

Intervention

Drug:
• TXA
Tranexamic acid injection 8mg/kg

Diagnostic Test:
• TEG6
performing thromboelastography (TEG6)

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Konkuk University Medical Center	Asan Medical Center, Korea Health Industry Development Institute, Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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