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

June 27, 2018 updated by: Angela Sa, CUF Santarém Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

• Patients of a median size private hospital in Portugal

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
intra-op single dose
intra-operative single dose of tranexamic acid
Drug: Tranexamic Acid
Tranexamic acid effect on perioperative bleeding in orthopedic surgery
intra-op dose and additional dose
intra-operative dose of tranexamic acid and additional dose 3 hours after
Drug: Tranexamic Acid
Tranexamic acid effect on perioperative bleeding in orthopedic surgery
intra-op dose and perfusion
intra-operative dose of tranexamic acid followed by a continuous infusion during 6 hours.
Drug: Tranexamic Acid
Tranexamic acid effect on perioperative bleeding in orthopedic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative bleeding
Time Frame: postoperative day 2
perioperative blood loss measured in mililiters (mL)
postoperative day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CUF Santarém Hospital

Investigators

  • Principal Investigator: Angela Sa, MD, CUF Santarem Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

June 27, 2018

First Posted (Actual)

June 29, 2018

Study Record Updates

Last Update Posted (Actual)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATX (Tranexamic acid )

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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