Hemostatic matrix effects on blood loss after total knee arthroplasty: A randomized controlled trial

Alexander Di Francesco, Stefano Flamini, Filippo Fiori, Franco Mastri, Alexander Di Francesco, Stefano Flamini, Filippo Fiori, Franco Mastri

Abstract

Background: Total knee arthroplasty (TKA) can result in major postoperative blood loss which can impact on the recovery and rehabilitation of patients. It also requires expensive transfusions. The purpose of the study was to investigate whether a hemostatic matrix, composed of cross-linked gelatin and a thrombin solution, would reduce blood loss in patients following TKA.

Materials and methods: THIS WAS A PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY (TRIAL REGISTRATION: Hospital S. Salvatore L'Aquila ADJ00843) conducted in 93 patients. Criteria for participation were unilateral TKA for osteoarthritis, and a preoperative hemoglobin level >13 g/dL. The outcomes measured were postoperative hemoglobin and hematocrit levels measured at 24h, 72 h, and 7 days. The mean total postoperative blood loss was calculated from drainage volume, patient blood volume, hematocrit, and red blood cell volume. In addition, the drain output within 24 h following surgery and any transfusion requirements were determined.

Results: Hemostatic matrix-treated patients (n = 51) showed significant reductions in calculated postoperative blood loss of 32.3% and 28.7% versus control in men and women, respectively (P < 0.01). Postoperative blood loss after 24 h in drain was significantly less with the hemostatic matrix versus control, as were decreases in hemoglobin levels 7 days post-surgery (each P < 0.01). Three patients in the control group required blood transfusion, whereas no blood transfusions were necessary in the hemostatic matrix group.

Conclusion: The use of a hemostatic matrix provides a safe and effective means to reduce blood loss and blood transfusion requirements in TKA.

Keywords: Blood loss; blood transfusion; hemostatic matrix; postoperative outcomes; total knee arthroplasty.

Conflict of interest statement

Conflict of Interest: None.

Figures

Figure 1
Figure 1
Patient flow through the study
Figure 2
Figure 2
A bar diagram showing mean drainage postoperative blood loss (after 24 h) in each group by gender
Figure 3
Figure 3
A bar diagram showing mean decrease in hemoglobin (after 7 days) in each group by gender
Figure 4
Figure 4
A bar diagram showing total calculated blood loss in each group by gender

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