Clinical trial NCT03019198: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss, Surgical
Tranexamic Acid Adverse Reaction
Hip Replacement
Keywords: Tranexamic Acid
Blood loss
Tranfusion
Lead sponsor: Instituto Nacional de Traumatologia e Ortopedia
Sponsor class: OTHER_GOV
First posted: 2017-01-12
Enrollment: 256
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hemoglobin drop
timeFrame: 24 hours post operative
measure: Hematocrit drop
timeFrame: 24 hours post operative
measure: Blood transfusion rate
timeFrame: 5 days
measure: Operative blood loss
timeFrame: 24 hours post operative
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: 7 days
measure: Systemic adverse events
timeFrame: 1 year
measure: Thromboembolic efects
timeFrame: 1 year
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Traumatologia e Ortopedia
Study officials:
References:
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.