TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL

Blood Loss, Surgical Clinical Trial

Official title:

TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019198
• Other study ID #: 06554913.0.0000.5273
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2017
• Last updated: March 7, 2017
• Start date: December 2013
• Est. completion date: March 2016

Study information

• Verified date: March 2017
• Source: Instituto Nacional de Traumatologia e Ortopedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients undergoing total hip arthroplasty (THA).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: March 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Hip Replacement
• Tranexamic Acid Adverse Reaction

Intervention

Drug:
• Tranexamic Acid Injectable Solution
Intravenous 15 mg per kilogram tranexamic acid
• Placebo - Concentrate

Locations

Country	Name	City	State
Brazil	Instituto Nacional de Traumatologia e Ortopedia	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Traumatologia e Ortopedia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin drop		24 hours post operative
Primary	Hematocrit drop		24 hours post operative
Primary	Blood transfusion rate		5 days
Primary	Operative blood loss		24 hours post operative
Secondary	Length of stay in hospital		7 days
Secondary	Systemic adverse events		1 year
Secondary	Thromboembolic efects		1 year