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

Sponsor

Konkuk University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05956769

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.8

Patients Per Site Per Month

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 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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis of Hip	Diagnostic Test: Tranexamic Acid Diagnostic Test: thromboelastography Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferiorParallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferior

Masking:

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

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 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: Tranexamic Acid Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr Diagnostic Test: thromboelastography thromboelastography (TEG6) Drug: Placebo Normal saline injection
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: Tranexamic Acid Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr Diagnostic Test: thromboelastography thromboelastography (TEG6)
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: Tranexamic Acid Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr Diagnostic Test: thromboelastography thromboelastography (TEG6) Drug: Placebo Normal saline injection
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: 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]
r-time of CRT test
CK alpha angle [24 hours]
alpha angle of CRT test
CRT maximal lysis [24 hours]
maximal lysis of CRT test
CFF maximal amplitude [24 hours]
maximal amplitude of CFF test
Hemoglobin [6 hours]
the lowest hemoglobin value before transfusion
packed RBC [6 hours]
transfused fresh frozen plasma
fresh frozen plasma [6 hours]
transfused fresh frozen plasma
cryoprecipitate [6 hours]
transfused cryoprecipitate
platelet [6 hours]
transfused platelet (apheresis) or platelet concentrate
seizure [48 hours]
postoperative incidence of seizure
thromboembolism [48 hours]
preoperative incidence of myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
postoperative bleeding [48 hours]
bleeding from surgical drain
re-operation [48 hours]
re-operation due to postoperative bleeding
intraoperative bleeding [4 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Konkuk University Medical Center	Seoul		Korea, Republic of	143-729
2	Soi Lee	Seoul		Korea, Republic of

Sponsors and Collaborators

Konkuk University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center

ClinicalTrials.gov Identifier:

NCT05956769

Other Study ID Numbers:

HI22C195200-1-2

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Tranexamic Acid

Study Results

No Results Posted as of Jul 21, 2023