Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty

Arthritis of Hip Clinical Trial

Official title:

Comparison of TEG-guided and Preemptive Tranexamic Acid Administration Strategies in Total Hip Replacement Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05956769
• Other study ID #: HI22C195200-1-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 vs Preemptive Tranexamic Acid Administration in total hip arthroplasty. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

Inclusion Criteria patients undergoing following surgery

• total hip arthroplasty

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 of Hip

Intervention

Drug:
• Tranexamic Acid
Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr

Diagnostic Test:
• thromboelastography
thromboelastography (TEG6)

Drug:
• Placebo
Normal saline injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

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	r-time of CRT test	24 hours
Secondary	CK alpha angle	alpha angle of CRT test	24 hours
Secondary	CRT maximal lysis	maximal lysis of CRT test	24 hours
Secondary	CFF maximal amplitude	maximal amplitude of CFF test	24 hours
Secondary	Hemoglobin	the lowest hemoglobin value before transfusion	6 hours
Secondary	packed RBC	transfused fresh frozen plasma	6 hours
Secondary	fresh frozen plasma	transfused fresh frozen plasma	6 hours
Secondary	cryoprecipitate	transfused cryoprecipitate	6 hours
Secondary	platelet	transfused platelet (apheresis) or platelet concentrate	6 hours
Secondary	seizure	postoperative incidence of seizure	48 hours
Secondary	thromboembolism	preoperative incidence of myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction	48 hours
Secondary	postoperative bleeding	bleeding from surgical drain	48 hours
Secondary	re-operation	re-operation due to postoperative bleeding	48 hours
Secondary	intraoperative bleeding	amount of intraoperative bleeding	4 hours