Blood Loss, Surgical, Tranexamic Acid Adverse Reaction, Hip Replacement
Conditions
Keywords
Tranexamic Acid, Blood loss, Tranfusion
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.
Interventions
Intravenous 15 mg per kilogram tranexamic acid
Sponsors
Instituto Nacional de Traumatologia e Ortopedia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin drop | 24 hours post operative |
| Hematocrit drop | 24 hours post operative |
| Blood transfusion rate | 5 days |
| Operative blood loss | 24 hours post operative |
Secondary
| Measure | Time frame |
|---|---|
| Systemic adverse events | 1 year |
| Thromboembolic efects | 1 year |
| Length of stay in hospital | 7 days |
Countries
Brazil
Outcome results
None listed