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

CUF Santarém Hospital

Status: Unknown

Conditions: Tranexamic Acid; Ankle Osteoarthritis; Knee Osteoarthritis; Bleeding

Treatments: Drug: Tranexamic Acid

Study type: Observational

Funder types: Other

Identifiers

NCT03573245

ATX (Tranexamic acid )

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

210 participants in 3 patient groups

intra-op single dose

Description:

intra-operative single dose of tranexamic acid

Treatment:

Drug: Tranexamic Acid

intra-op dose and additional dose

Description:

intra-operative dose of tranexamic acid and additional dose 3 hours after

Treatment:

Drug: Tranexamic Acid

intra-op dose and perfusion

Description:

intra-operative dose of tranexamic acid followed by a continuous infusion during 6 hours.

Treatment:

Drug: Tranexamic Acid