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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups
Randomly assigned \[1:1 ratio\] using a computer generated table of random numbers to 1 of the 2 intervention groups
Miriam Hospital
Providence, Rhode Island, United States
Assessment of changes in hemostasis via viscoelastic testing.
To compare the magnitude of lysis via lysis indexes.
Time frame: intraoperative (min)
Hematocrit
The comparison of hematocrit recordings from preoperative period to the postoperative period
Time frame: postoperative day 1
Length of Hospitalization
Length of hospital stay from day of surgery to discharge from hospital.
Time frame: up to 7 days
The number of blood transfusions
The number of blood products transfused after surgery
Time frame: 90 days
Hospital readmissions
The occurrence of hospital readmissions following surgery
Time frame: 90 days
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