Tranexamic Acid in Revision Total Joint Arthroplasty



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:6/10/2018
Start Date:April 2016
End Date:December 1, 2019
Contact:Craig J Della Valle, MD
Email:dellavalle.research@rushortho.com
Phone:312-432-2468

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Tranexamic Acid in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial

To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA)
[single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral
repeated dosing] to minimize post-operative blood loss and transfusion requirements following
revision total knee arthroplasty (RTKA).

Study Design: Prospective randomized control study

Scientific Background/Intro: Total hip or knee arthroplasty is associated with the risk of
moderate to significant blood loss. Approximately one-third of patients undergoing total
joint replacement surgery require one to three units of blood postoperatively. Tranexamic
acid is a synthetic antifibrinolytic agent that has been successfully used orally,
intravenously, and topically to control bleeding after total joint replacement. The use of
TXA has been shown to significantly reduce the need for blood products during total joint
replacement.1-3

Many studies have explored the use of various TXA regimens following primary TKA. Tanaka et
al. demonstrated both that pre-operative administration of TXA was superior to
intra-operative administration and that a double dose regimen is superior to a single dose
regimen.4 Maniar et al. further supported the idea that pre-operative TXA administration is
superior, and the addition of higher doses of TXA improved efficacy without an increase in
thromboembolic complications.5 More recently, Lin et al. demonstrated that combining a
pre-operative IV dose of TXA with an intra-articular dose after arthrotomy closure was
superior to an intra-articular dose alone.6 Also, in an unpublished randomized control trial
that we recently completed, we found oral TXA to provide equivalent blood control at a lower
cost than IV TXA.

It is well known that revision joint arthroplasty cases are more complex than primary joint
replacements. Revision total knee arthroplasty is associated with a greater risk of blood
loss and increased transfusion rates compared to primary TKA.7 Despite the vast body of
literature investigating TXA following primary TKA, only three retrospective studies have
been published on the use of TXA after revision TKA.8-10 All three studies have shown that IV
TXA decreased both the rate of transfusions and the amount of blood transfused when compared
to controls.8-10

Although the TXA formulations used in primary TKA have been shown to be effective in the
retrospective studies, the amount of blood loss and risk of transfusion still remains
significantly higher than during primary TKA. By performing the first randomized control
trial on the use of TXA following revision TKA, we believe it will help change practice
patterns by providing evidence that the same TXA formulations used in primary TKA are
inadequate for revision TKA. Additionally, we will be exploring new combinations of TXA
administration to answer some questions brought up by previous studies in regards to the
optimal TXA regimen.

Inclusion Criteria:

- Patients scheduled for revision THA or TKA defined as femoral component exchange,
acetabulum/tibial component exchange, both component exchange, explant of both
components and placement of antibiotic cement spacer, or a second stage
re-implantation procedure.

Exclusion Criteria:

- Patients scheduled for a head and liner/poly exchange, known allergy to TXA, acquired
disturbances of color vision, refusal of blood products, pre-operative use of
anticoagulant therapy within five days before surgery, a history of arterial or venous
thrombotic disease (including a history of Deep Vein Thrombosis (DVT), Pulmonary
Embolism (PE), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA)),
pregnancy, breastfeeding, or major co-morbidities (myocardial infarction or stent
placement within one year, severe pulmonary disease, renal impairment, or hepatic
failure).
We found this trial at
3
sites
Rochester, Minnesota 55905
Phone: 507-538-3562
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Craig Della Valle, MD
Phone: 312-432-2350
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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New York, New York 10021
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