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Randomized Controlled Trial Comparative Study
Comparison of Floseal® and Tranexamic Acid for Bleeding Control after Total Knee Arthroplasty: a Prospective Randomized Study.
- Camilo Partezani Helito, Marcelo Batista Bonadio, Marcel Faraco Sobrado, Pedro Nogueira Giglio, José Ricardo Pécora, Gilberto Luis Camanho, and Marco Kawamura Demange.
- Departamento de Ortopedia e Traumatologia, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.
- Clinics (Sao Paulo). 2019 Jan 1; 74: e1186.
ObjectiveTranexamic acid (TXA) and the hemostatic agent Floseal® have already been used to minimize bleeding during total knee arthroplasty (TKA).MethodsWe 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.ResultsThe 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.ConclusionThe 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.
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