The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty - A prospective, randomized, multicenter study

Background Total knee arthroplasty is associated with major postoperative b lood loss of approximately 800 to 1200 milliliters, and blood transfusion i s frequently required. With the increased concern about the risks of blood transfusion, various methods of blood conservation in orthopaedic surgery h ave been studied. The most appropriate solution, however, is to reduce the loss of blood during and after an operation. The present prospective, contr olled, randomized study was designed to evaluate the hemostatic efficacy of the use of fibrin tissue adhesive in patients managed with total knee arth roplasty. Methods: Fifty-eight patients who were scheduled to have a total knee arthr oplasty were randomly divided into two groups: a control group, in which th e standard means of hemostasis were applied, and a treatment group, in whic h the standard means to control local bleeding sere applied and a fibrin ti ssue adhesive was sprayed on the internal aspects of the operative field be fore skin closure, All operations were performed in a bloodless field with use of a pneumatic tourniquet, All patients received low-molecular-weight h eparin as thromboprophylaxis twelve hours before the operation and every tw elve hours postoperatively Blood loss during the operation was evaluated by measuring the volume in the suction apparatus and by estimating the amount of lost blood in the swabs at the end of the operation. The apparent posto perative lost blood was determined by measuring the volume in the suction-d rain bottles. All blood transfusions were recorded, Results: The mean apparent postoperative blood loss land standard deviation ) in the fibrin-tissue-adhesive group was 360 +/- 287.7 milliliters compare d with 878 +/- 403.0 milliliters in the control group, with a mean differen ce of 518 milliliters (p < 0.001). The decrease in the level of hemoglobin was 25 +/- 10 grams per liter in the treatment group compared with 37 +/- 1 2 grams per Liter in the control group (p < 0.001). Sixteen patients (55 pe rcent) in the control group required a blood transfusion and eight (28 perc ent) required two units of blood, whereas only five (17 percent) of the pat ients in the fibrin-tissue-adhesive group required a blood transfusion and only one (3 percent) required tno units (p = 0.004), The number of adverse events was comparable between the two groups. None of the adverse events we re considered to be related to the use of fibrin tissue adhesive, One death , which was due to massive pulmonary embolism, was reported in the control group. No seroconversion was reported at three and six months after the ope ration, Conclusion: The use of fibrin tissue adhesive in total knee arthroplasty se ems to be an effective and safe means with which to reduce blood Loss and b lood-transfusion requirements. Furthermore, the importance of these finding s was enhanced by a significant reduction in blood loss, in the postoperati ve decrease in the level of hemoglobin, and in blood-transfusion requiremen ts despite preoperative thromboprophylaxis with low-molecular-weight hepari n.