Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty

Phase 2

Completed

Conditions: Acute Blood Loss Anemia
Osteoarthritis, Knee

Interventions: Drug: Placebo
Drug: Tranexamic Acid

Registration Number: NCT01370460

Lead Sponsor: Henry Ford Health System

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	100mL 0.9% NS, applied topically
Tranexamic Acid	Tranexamic Acid	Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.

Primary Outcome Measures

Name	Time	Method
Blood Loss	participants will be followed for the duration of hospital stay, an expected average of 3 days	Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146).

Secondary Outcome Measures

Name	Time	Method
Postoperative Transfusion Rate	participants will be followed for the duration of hospital stay, an expected average of 3 days	Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of \< 8.0g/dL hemoglobin, or any hemoglobin \<7.0 g/dL, precipitated transfusion.