Back to resultsGoal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty
Primary Purpose
Arthritis of Hip
Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tranexamic Acid
thromboelastography
Placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Arthritis of Hip
Eligibility Criteria
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
Sites / Locations
- Konkuk University Medical Center
- Soi Lee
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
Empirical 1: TXA and Placebo administration
Empirical 2: TXA administration
Goal-directed 1: Placebo administration
Goal-directed 2: TXA and Placebo administration
Arm Description
Tranexamic acid administration, regardless of the result of TEG6. Placebo administration, at LY30> 3% or MA<54 mm in CRT of TEG6
Tranexamic acid administration, regardless of the result of TEG6. Placebo discard, at LY30< 3% or MA > 54 mm in CRT of TEG6
Tranexamic acid administration, regardless of the result of TEG6. Placebo administration, at LY30> 3% or MA<54 mm in CRT of TEG6
Tranexamic acid administration, regardless of the result of TEG6. Placebo discard, at LY30 < 3% or MA > 54 mm in CRT of TEG6
Outcomes
Primary Outcome Measures
CRT maximal amplitude
maximal amplitude of CRT test
Secondary Outcome Measures
CK reaction time
r-time of CRT test
CK alpha angle
alpha angle of CRT test
CRT maximal lysis
maximal lysis of CRT test
CFF maximal amplitude
maximal amplitude of CFF test
Hemoglobin
the lowest hemoglobin value before transfusion
packed RBC
transfused fresh frozen plasma
fresh frozen plasma
transfused fresh frozen plasma
cryoprecipitate
transfused cryoprecipitate
platelet
transfused platelet (apheresis) or platelet concentrate
seizure
postoperative incidence of seizure
thromboembolism
preoperative incidence of myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
postoperative bleeding
bleeding from surgical drain
re-operation
re-operation due to postoperative bleeding
intraoperative bleeding
Full Information
NCT ID
NCT05956769
First Posted
July 12, 2023
Last Updated
July 12, 2023
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05956769
Brief Title
Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty
Official Title
Comparison of TEG-guided and Preemptive Tranexamic Acid Administration Strategies in Total Hip Replacement Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis of Hip
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferior
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Empirical 1: TXA and Placebo administration
Arm Type
Active Comparator
Arm Description
Tranexamic acid administration, regardless of the result of TEG6. Placebo administration, at LY30> 3% or MA<54 mm in CRT of TEG6
Arm Title
Empirical 2: TXA administration
Arm Type
Active Comparator
Arm Description
Tranexamic acid administration, regardless of the result of TEG6. Placebo discard, at LY30< 3% or MA > 54 mm in CRT of TEG6
Arm Title
Goal-directed 1: Placebo administration
Arm Type
Experimental
Arm Description
Tranexamic acid administration, regardless of the result of TEG6. Placebo administration, at LY30> 3% or MA<54 mm in CRT of TEG6
Arm Title
Goal-directed 2: TXA and Placebo administration
Arm Type
Experimental
Arm Description
Tranexamic acid administration, regardless of the result of TEG6. Placebo discard, at LY30 < 3% or MA > 54 mm in CRT of TEG6
Intervention Type
Diagnostic Test
Intervention Name(s)
Tranexamic Acid
Intervention Description
Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr
Intervention Type
Diagnostic Test
Intervention Name(s)
thromboelastography
Intervention Description
thromboelastography (TEG6)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline injection
Primary Outcome Measure Information:
Title
CRT maximal amplitude
Description
maximal amplitude of CRT test
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
CK reaction time
Description
r-time of CRT test
Time Frame
24 hours
Title
CK alpha angle
Description
alpha angle of CRT test
Time Frame
24 hours
Title
CRT maximal lysis
Description
maximal lysis of CRT test
Time Frame
24 hours
Title
CFF maximal amplitude
Description
maximal amplitude of CFF test
Time Frame
24 hours
Title
Hemoglobin
Description
the lowest hemoglobin value before transfusion
Time Frame
6 hours
Title
packed RBC
Description
transfused fresh frozen plasma
Time Frame
6 hours
Title
fresh frozen plasma
Description
transfused fresh frozen plasma
Time Frame
6 hours
Title
cryoprecipitate
Description
transfused cryoprecipitate
Time Frame
6 hours
Title
platelet
Description
transfused platelet (apheresis) or platelet concentrate
Time Frame
6 hours
Title
seizure
Description
postoperative incidence of seizure
Time Frame
48 hours
Title
thromboembolism
Description
preoperative incidence of myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
Time Frame
48 hours
Title
postoperative bleeding
Description
bleeding from surgical drain
Time Frame
48 hours
Title
re-operation
Description
re-operation due to postoperative bleeding
Time Frame
48 hours
Title
intraoperative bleeding
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Soi Lee
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty
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