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Trial record 12 of 419 for:    TRANEXAMIC ACID

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

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ClinicalTrials.gov Identifier: NCT03573245
Recruitment Status : Not yet recruiting
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Angela Sa, CUF Santarém Hospital

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
Tranexamic Acid Knee Osteoarthritis Ankle Osteoarthritis Bleeding 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.


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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Perioperative bleeding [ Time Frame: postoperative day 2 ]
    perioperative blood loss measured in mililiters (mL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
• Patients of a median size private hospital in Portugal
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573245


Contacts
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Contact: Angela Sa, MD +351243240240 angela.sa@jmellosaude.pt
Contact: Vania Simoes, MD +351243240240 vania.simoes@jmellosaude.pt

Sponsors and Collaborators
CUF Santarém Hospital
Investigators
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Principal Investigator: Angela Sa, MD CUF Santarem Hospital

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Responsible Party: Angela Sa, MD, CUF Santarém Hospital
ClinicalTrials.gov Identifier: NCT03573245     History of Changes
Other Study ID Numbers: ATX (Tranexamic acid )
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tranexamic Acid
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants