Randomized Tranexamic Acid Total Knee Arthroplasty



Status:Not yet recruiting
Conditions:Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:April 2014
End Date:December 2018

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Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical

The major cause of postoperative blood loss following TKA can be attributed to surgical
trauma that leads to activation of both the coagulation cascade and local fibrinolysis.(22,
23)(12) The fibrinolysis is further compounded by tourniquet release at the end of the
surgical procedure.(23) Multiple studies and meta-analyses have shown that intravenous (IV)
administration of the antifibrinolytic agent tranexamic acid (TA) reduces postoperative
bleeding and the need for transfusion.(12)(24-31) Tranexamic acid is a synthetic derivative
of the amino acid lysine and a a competitive inhibitor of plasminogen activation that
interferes with fibrinolysis.(27)

However, concerns about the safety of systemic administration of tranexamic acid have
hindered its widespread use even though multiple studies and meta-analyses have shown no
increased risk (12)(24-31). In particular, orthopedic surgeons have been concerned with the
risk of thromboembolic diseases such as deep-vein thrombosis (DVT) and pulmonary embolism
(PE) in high-risk patients. However, multiple prospective and retrospective studies, in
addition to meta-analyses, have shown absolutely no increase in DVT or PE. Regardless, an
alternative includes the topical application of tranexamic acid to the knee joint before
closure. While topical application of tranexamic acid has been shown to be a cost-effective
and simple route of reducing blood loss in dental, cardiac, and spine procedures, less data
is available in regards to total knee arthroplasty.(12) As such, the goal of this
randomized controlled, single-blinded, multicenter trial is to assess the efficacy of
topical tranexamic acid compared to a control group of patients receiving IV tranexamic
acid.


Inclusion Criteria:

All patients will be undergoing a primary unilateral total knee arthroplasty for a
diagnosis of osteoarthritis.

Exclusion Criteria:

- Younger than 18 or greater than 100 years of age

- Pregnant

- Breastfeeding

- Allergy to tranexamic acid

- Preoperative hepatic or renal dysfunction

- Serious cardiac or respiratory disease including coronary artery stent placement

- Congenital or acquired coagulopathy as evidence by INR > 1.4 or PTT > 1.4 times
normal

- Thrombocytopenia as identified by a preoperative platelet count of < 1550,000/mm3

- History of thromboembolic disease

- Donated preoperative autologous blood.

- Diagnosis of inflammatory arthritis

- Preoperative hemoglobin < 10g/dL
We found this trial at
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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