Back to resultsTRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
Primary Purpose
Blood Loss, Surgical, Tranexamic Acid Adverse Reaction, Hip Replacement
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Tranexamic Acid Injectable Solution
Placebo - Concentrate
Sponsored by
About this trial
This is an interventional treatment trial for Blood Loss, Surgical focused on measuring Tranexamic Acid, Blood loss, Tranfusion
Eligibility Criteria
Inclusion Criteria:
- Consecutive patients who need total hip replacement were included in the initial sample. There was no age limit or restriction regarding gender for admission to the study.
Exclusion Criteria:
- Patients who underwent previous surgery in the same joint, evidence of joint infection, congenital or acquired coagulopathies, active intravascular coagulation, acute occlusive vasculopathy, hypersensitivity to TXA, chronic use of oral and steroid anticoagulants, history of severe or moderate allergy to plasma transfusion, chronic heart disease, malignant neoplasms and autoimmune diseases, patients who needed bone graft or underwent hip arthroplasty revision surgeries, and who did not consent to participate in the study
Sites / Locations
- Instituto Nacional de Traumatologia e Ortopedia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TXA
Control
Arm Description
Performed an intravenous bolus administration of 15 mg/kg of TXA to the volunteers after the end of the anesthesia and 15 minutes prior to skin incision.
This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication.
Outcomes
Primary Outcome Measures
Hemoglobin drop
Hematocrit drop
Blood transfusion rate
Operative blood loss
Secondary Outcome Measures
Length of stay in hospital
Systemic adverse events
Thromboembolic efects
Full Information
NCT ID
NCT03019198
First Posted
January 10, 2017
Last Updated
March 7, 2017
Sponsor
Instituto Nacional de Traumatologia e Ortopedia
1. Study Identification
Unique Protocol Identification Number
NCT03019198
Brief Title
TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
Official Title
TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Traumatologia e Ortopedia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients undergoing total hip arthroplasty (THA).
Detailed Description
This was a prospective, experimental, randomized, controlled study of 308 consecutive patients who underwent primary THA from December 2013 to March 2014. 256 volunteers remained in the study, 128 were treated 15 mg/kg intravenous bolus of TXA and 128 did not receive the medication. Participants were followed up at 3 weeks, 3 months, 6 months, 1 year, and then annually after surgery.
The use of TXA resulted in lesser reduction in hemoglobin and hematocrit levels, reduced blood loss, blood transfusion rate, volume of blood products, and stay length even in risk factor patients.
TXA protects risk factor patients against intra and postoperative bleeding and reduces transfusion rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Tranexamic Acid Adverse Reaction, Hip Replacement
Keywords
Tranexamic Acid, Blood loss, Tranfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TXA
Arm Type
Experimental
Arm Description
Performed an intravenous bolus administration of 15 mg/kg of TXA to the volunteers after the end of the anesthesia and 15 minutes prior to skin incision.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid Injectable Solution
Other Intervention Name(s)
Lysteda, Transamin
Intervention Description
Intravenous 15 mg per kilogram tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Placebo - Concentrate
Primary Outcome Measure Information:
Title
Hemoglobin drop
Time Frame
24 hours post operative
Title
Hematocrit drop
Time Frame
24 hours post operative
Title
Blood transfusion rate
Time Frame
5 days
Title
Operative blood loss
Time Frame
24 hours post operative
Secondary Outcome Measure Information:
Title
Length of stay in hospital
Time Frame
7 days
Title
Systemic adverse events
Time Frame
1 year
Title
Thromboembolic efects
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Consecutive patients who need total hip replacement were included in the initial sample. There was no age limit or restriction regarding gender for admission to the study.
Exclusion Criteria:
Patients who underwent previous surgery in the same joint, evidence of joint infection, congenital or acquired coagulopathies, active intravascular coagulation, acute occlusive vasculopathy, hypersensitivity to TXA, chronic use of oral and steroid anticoagulants, history of severe or moderate allergy to plasma transfusion, chronic heart disease, malignant neoplasms and autoimmune diseases, patients who needed bone graft or underwent hip arthroplasty revision surgeries, and who did not consent to participate in the study
Facility Information:
Facility Name
Instituto Nacional de Traumatologia e Ortopedia
City
Rio de Janeiro
ZIP/Postal Code
20940070
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31814452
Citation
Kimura OS, Freitas EH, Duarte ME, Cavalcanti AS, Fernandes MB. Tranexamic acid use in high-risk blood transfusion patients undergoing total hip replacement: a randomised controlled trial. Hip Int. 2021 Jul;31(4):456-464. doi: 10.1177/1120700019889947. Epub 2019 Dec 9.
Results Reference
derived
Learn more about this trial
TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
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