Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA), Anemia
Therapuetic Areas:Hematology, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:5/27/2013
Start Date:June 2011
End Date:May 2012
Contact:Michael Laker, M.D.
Email:mlaker1@hfhs.org
Phone:248-514-8212

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This study aims to assess postoperative blood loss and transfusion rates in total knee
replacement after one-time administration of topical tranexamic acid.


Autologous (donor) blood transfusion is an expensive and common occurrence after total knee
replacement. Published data puts this rate between 9 and 40% after primary unilateral total
knee arthroplasty. There have been many proposed adjunctive measures to decrease
intraoperative and postoperative blood loss during such surgery. Most of these include
thrombin inhibition, so-called "minimally- invasive" techniques or instrumentation, or other
adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the
clotting cascade, has been used extensively in multiple areas of surgery with multiple
studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental
swishing solution after tooth extraction. There have been small studies evaluating
intravenous tranexamic acid and its effect on total knee replacement, with some promising
results. The topical form of TA has been evaluated in only one prospective, randomized
clinical trial with a significant decrease in postoperative blood loss and a trend towards
decreased autologous blood transfusion rates. This study proposes to further evaluate
tranexamic acid as an inexpensive and viable option for use in total knee arthroplasty. The
topical form of the drug has been shown to achieve these hemostatic effects without
increasing the risk of blood clots after surgery. Furthermore, the one aforementioned
randomized clinical trial used a variety of postoperative deep vein thrombosis prophylaxis
after surgery and introduced a potential confounding variable. A rigorous analysis of the
effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced
at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an
identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.

Inclusion Criteria:

- All adult patients over age eighteen

- Primary unilateral total knee arthroplasty at Henry Ford Hospital (Detroit, Michigan,
United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan,
United States)

Exclusion Criteria:

- patient history of venous thromboembolic disease or coagulopathy

- use of anticoagulant medications within 7 days of surgery

- history of arterial embolic disease

- history of Class III or IV heart failure

- renal failure

- intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication
(MI, intraoperative fracture, vasopressor support, emergent intubation).
We found this trial at
1
site
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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mi
from
Detroit, MI
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