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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03573245
Enrollment
210
Registered
2018-06-29
Start date
2018-07-01
Completion date
2019-04-01
Last updated
2018-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Osteoarthritis, Bleeding, Knee Osteoarthritis, Tranexamic Acid

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.

Interventions

DRUGTranexamic Acid

Tranexamic acid effect on perioperative bleeding in orthopedic surgery

Sponsors

CUF Santarém Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Perioperative bleedingpostoperative day 2perioperative blood loss measured in mililiters (mL)

Contacts

Primary ContactAngela Sa, MD
angela.sa@jmellosaude.pt+351243240240
Backup ContactVania Simoes, MD
vania.simoes@jmellosaude.pt+351243240240

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026