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NCT03573245 Clinical Trial

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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03573245
Other study ID # ATX (Tranexamic acid )
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date April 1, 2019

Study information
Verified date June 2018
Source CUF Santarém Hospital
Contact Angela Sa, MD
Phone +351243240240
Email angela.sa@jmellosaude.pt
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 210
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic Acid
Tranexamic acid effect on perioperative bleeding in orthopedic surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
CUF Santarém Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Perioperative bleeding perioperative blood loss measured in mililiters (mL) postoperative day 2
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