Tranexamic Acid for Total Knee Arthroscopy

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-29

Study Completion Date

2021-01-08

Brief Summary

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The purpose of this investigation is to determine the most effective regimen of administration of tranexamic acid to improve clinical outcome among patients undergoing total knee arthroplasty.

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Detailed Description

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Tranexamic acid (TXA) is synthetic lysine analog, which acts as anti-fibrinolytic agent by preventing conversion of plasminogen in to plasmin. Various regimens of TXA administration (routes, doses, timing) have been used to decrease perioperative blood loss and improve clinical outcomes among patients undergoing different orthopedic surgeries. We are conducting this prospective randomized placebo controlled trial to compare the effect of the two most common regimens of TXA administration on hemostasis and clinical outcomes among patients undergoing total knee arthroplasty. All recruited patients receive the first dose of 15mg/kg of IV TXA prior to skin incision. The second dose of 15mg/kg IV TXA or identical placebo is administered prior to the release of the tourniquet.

The assessment of hemostasis is performed using whole blood sample via viscoelastic testing by rotational thromboelastography (ROTEM). A blood sample is collected in the preoperative area and after the administration of each dose of TXA. Clinical data is collected until 90 days after surgery.

Conditions

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Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tranexamic acid (TXA)

All patients will receive 15 mg/kg Tranexamic acid (TXA) IV prior to skin incision. This arm will receive a second intravenous dose of 15 mg/kg of Tranexamic acid (TXA) before the release of the tourniquet. The medication is delivered from the pharmacy in a masked syringe labeled as "study medication."

Group Type ACTIVE_COMPARATOR

Tranexamic acid (TXA)

Intervention Type DRUG

Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups

Placebo Normal Saline (NS)

All patients will receive 15 mg/kg Tranexamic acid (TXA) IV prior to skin incision. This arm will receive a second intravenous dose of placebo (Normal Saline) in the volume calculated to be equal to the volume of 15 mg/kg of TXA. The medication is delivered from the pharmacy in a masked syringe labeled as "study medication."

Group Type PLACEBO_COMPARATOR

Placebo Normal Saline (NS)

Intervention Type DRUG

Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups

Interventions

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Tranexamic acid (TXA)

Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups

Intervention Type DRUG

Placebo Normal Saline (NS)

Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups

Intervention Type DRUG

Other Intervention Names

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Lysteda Cyklokapron Sodium chloride

Eligibility Criteria

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Inclusion Criteria

\- Adult patients who are scheduled to undergo total knee arthroplasty will be approached to participate.

Exclusion Criteria

* Known allergy to TXA
* History of venous or arterial thrombosis within 12 months
* History of thromboembolic event within 12 months
* Acute ischemic event (stroke, transient ischemic attack, myocardial infarction, ischemic retinopathy) within 6 months
* Known congenital thrombophilia

Relative Contraindications:

* History of seizures
* Impaired kidney function (Glomerular filtration rate \< 30 ml/min)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No