Comparison of Floseal® and Tranexamic Acid for Bleeding Control after Total Knee Arthroplasty: a Prospective Randomized Study

Abstract

OBJECTIVE:Tranexamic acid (TXA) and the hemostatic agent Floseal® have already been used to minimize bleeding during total knee arthroplasty (TKA).METHODS:We conducted a prospective, randomized study of 90 patients with indications for TKA. Following inclusion, the participants were randomly allocated in blocks to the following 3 groups: control, Floseal® and TXA. Bleeding parameters, including decreases in hemoglobin (Hb), drain output, number of blood transfusions and complications, were assessed. ClinicalTrials.gov: NCT02152917.RESULTS:The mean decrease in Hb was highest in the control group (4.81±1.09 g/dL), followed by the Floseal® (3.5±1.03 g/dL) and TXA (3.03±1.2 g/dL) groups. The Floseal® and TXA groups did not differ, and both performed better than the control group. The mean total drain output was 901.3±695.7 mL in the control group, 546.5±543.5 mL in the TXA group and 331.2±278.7 mL in the Floseal® group. Both TXA and Floseal® had significantly less output than the control group, and Floseal® had significantly less output than TXA. The number of blood transfusions was very small in all 3 groups.CONCLUSION:The use of TXA or Floseal® was associated with less blood loss than that of the control group among patients undergoing primary TKA, as measured both directly (intraoperative bleeding + drainage) and on the basis of a decrease in Hb, without differences in the rate of complications. TXA and Floseal® showed similar decreases in Hb and total measured blood loss, but the drain output was smaller in the Floseal® group.

Complications of Tranexamic Acid in Orthopedic Lower Limb Surgery: A Meta-Analysis of Randomized Controlled Trials

“…Overall, 9,067 patients received TXA while 6,592 were included in the control groups. With regard to the type of surgery, 82 studies [ 21 – 24 , 26 – 28 , 30 , 31 , 34 – 38 , 40 , 45 , 47 , 49 – 51 , 55 – 58 , 60 , 61 , 63 , 65 , 66 , 70 , 72 , 73 , 75 , 76 , 78 – 82 , 84 , 85 , 87 , 88 , 90 , 92 , 93 , 96 , 98 , 99 , 104 – 111 , 113 , 114 , 117 – 119 , 121 , 123 , 124 , 126 – 128 , 130 , 134 – 137 , 140 – 142 , 146 , 147 , 151 , 153 , 154 , 156 ] (5,267 cases and 3,498 controls) were focused on TKA, 41 studies [ 11 , 12 , 25 , 32 , 33 , 42 – 44 , 48 , 52 – 54 , 62 , 64 , 67 – …”

Scalpel can achieve better clinical outcomes compared with electric cautery in primary total knee arthroplasty: a comparison study

“…Similarly, studies have confirmed that topical use of TXA can obtain similar clinical effects as intravenous use of TXA, and the less possibility of complications [20,21]. In addition, other studies have pointed out that the topical use of the hemostatic agent, such as Floseal®, has achieved significant results in controlling blood loss during TKA [22][23][24][25]. In the present study, in order to reduce the related complications caused by blood loss, all of our patients have combined intravenous and topical use of TXA.…”

Efficacy of Extended Oral Tranexamic Acid on Blood Loss in Primary Total Knee Arthroplasty

“…In a study, Helito et al 23 compared IV TXA, topical hemostatic agents, and placebo; and reported that TXA had results comparable to those of topical hemostatic agents in terms of postoperative Hb reduction, and TXA was associated with less blood loss compared with placebo.…”