Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen

• Conditions: Tranexamic Acid; Knee Osteoarthritis; Ankle Osteoarthritis; Bleeding
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT03573245
• Lead Sponsor: CUF Santarém Hospital

Brief Summary

Tranexamic acid has been shown to be effective in reducing blood loss and transfusion in orthopedic surgery. It remains unknown the ideal therapeutic regimen. The goal of this study is to compare 3 dosage regimen of tranexamic acid in patients submitted to major orthopedic surgery.

Detailed Description

There is ongoing debate, however, around optimal perioperative tranexamic acid dosing, which varies widely.

A large number of studies comparing tranexamic acid to placebo, overall blood loss and transfusion requirements are both reduced by ≈30%. A well designed tranexamic acid trial will provide answers to the best regimen dosage for perioperative tranexamic acid use. It will benefit patients by reducing allogeneic transfusions and their associated risks and costs, thus adding value to the care delivered.

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-27
• Last Update Submitted: 2018-06-27
• Study First Posted: 2018-06-29
• Last Update Posted: 2018-06-29
• Study Start: 2018-07-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Age ≥ 18 anos
• Total ankle arthroplasty
• Total knee arthroplasty
• Weight >50 kilogram

Exclusion Criteria

• Allergy and Hypersensitivity to tranexamic acid
• Thromboembolic events history
• Epilepsy
• Acute kidney injury, Glomerular Filtration Rate < 50 ml/min
• Coagulation disorders
• Surgical reintervention
• Blood transfusion refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intra-op dose and perfusion	Tranexamic Acid	intra-operative dose of tranexamic acid followed by a continuous infusion during 6 hours.
intra-op single dose	Tranexamic Acid	intra-operative single dose of tranexamic acid
intra-op dose and additional dose	Tranexamic Acid	intra-operative dose of tranexamic acid and additional dose 3 hours after

Primary Outcome Measures

Name	Time	Method
Perioperative bleeding	postoperative day 2	perioperative blood loss measured in mililiters (mL)