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

Sponsor
CUF Santarém Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03573245
Collaborator
(none)
210
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid

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 Design

Study Type:
Observational
Anticipated Enrollment :
210 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen
Anticipated Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Apr 1, 2019
Anticipated Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Perioperative bleeding [postoperative day 2]

    perioperative blood loss measured in mililiters (mL)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • CUF Santarém Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Angela Sa, MD, CUF Santarém Hospital
ClinicalTrials.gov Identifier:
NCT03573245
Other Study ID Numbers:
  • ATX (Tranexamic acid )
First Posted:
Jun 29, 2018
Last Update Posted:
Jun 29, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Tranexamic Acid

Study Results

No Results Posted as of Jun 29, 2018