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

NCT ID: NCT03573245

Last Updated: 2018-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-04-01

Brief Summary

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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

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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.

Conditions

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Tranexamic Acid Knee Osteoarthritis Ankle Osteoarthritis Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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intra-op single dose

intra-operative single dose of tranexamic acid

Tranexamic Acid

Intervention Type DRUG

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

Tranexamic Acid

Intervention Type DRUG

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.

Tranexamic Acid

Intervention Type DRUG

Tranexamic acid effect on perioperative bleeding in orthopedic surgery

Interventions

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Tranexamic Acid

Tranexamic acid effect on perioperative bleeding in orthopedic surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CUF Santarém Hospital

OTHER

Sponsor Role lead

Responsible Party

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Angela Sa

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angela Sa, MD

Role: PRINCIPAL_INVESTIGATOR

CUF Santarem Hospital

Central Contacts

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Angela Sa, MD

Role: CONTACT

Phone: +351243240240

Email: [email protected]

Vania Simoes, MD

Role: CONTACT

Phone: +351243240240

Email: [email protected]

Other Identifiers

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ATX (Tranexamic acid )

Identifier Type: -

Identifier Source: org_study_id