Prospective randomized evaluation of a collagen/thrombin and autologous platelet hemostatic agent during total knee arthroplasty.

The purpose of this study was to evaluate the effectiveness of a collagen/thrombin and autologous platelet hemostatic agent in preventing blood loss during primary total knee arthroplasty. This prospective, double-blinded, randomized study was designed to enroll a total of 100 patients. Patients were randomized 1:1 to either the treatment arm (standard hemostasis plus study product) or the control arm (standard hemostasis alone). Transfusion requirements, as determined by a blinded investigator using standardized criteria, were significantly lower in the treatment group (no blood transfusions) compared with the control group (5 transfusions; P = .007). These data support the addition of the study product to prevent blood transfusions after primary total knee arthroplasty.

RCT Entities:   Population Interventions Outcomes