PURPOSE: To evaluate the hemostatic effect of intraarticular injection of a thrombin-based hemostatic agent in total knee arthroplasty (TKA). MATERIALS AND METHODS: We performed a prospective randomized controlled trial on the use of a thrombin-based hemostatic agent in patients undergoing unilateral TKA. A total of 100 TKA patients were enrolled, with 50 patients randomized into the study group and the other 50 patients into the controlled group. Drain output, hemoglobin level, total red blood cell loss for 24 hours after surgery, transfusion rates, and complications were assessed. RESULTS:Postoperative drain output was 525 mL in the study group and 667 mL in the control group (p=0.01). Nine patients in the study group and eighteen in the control group received blood transfusion (p=0.043). But, there was no significant difference between two groups in terms of hemoglobin level change and total red blood cell loss (p>0.05). CONCLUSIONS: The thrombin-based hemostatic agent demonstrated efficacy in reducing drain output and blood transfusion rates. Thus, we believe the use of a thrombin-based hemostatic agent should be considered as an option in orthopedic surgery that involves massive bleeding.
RCT Entities:
PURPOSE: To evaluate the hemostatic effect of intraarticular injection of a thrombin-based hemostatic agent in total knee arthroplasty (TKA). MATERIALS AND METHODS: We performed a prospective randomized controlled trial on the use of a thrombin-based hemostatic agent in patients undergoing unilateral TKA. A total of 100 TKA patients were enrolled, with 50 patients randomized into the study group and the other 50 patients into the controlled group. Drain output, hemoglobin level, total red blood cell loss for 24 hours after surgery, transfusion rates, and complications were assessed. RESULTS: Postoperative drain output was 525 mL in the study group and 667 mL in the control group (p=0.01). Nine patients in the study group and eighteen in the control group received blood transfusion (p=0.043). But, there was no significant difference between two groups in terms of hemoglobin level change and total red blood cell loss (p>0.05). CONCLUSIONS: The thrombin-based hemostatic agent demonstrated efficacy in reducing drain output and blood transfusion rates. Thus, we believe the use of a thrombin-based hemostatic agent should be considered as an option in orthopedic surgery that involves massive bleeding.
Authors: W L Healy; B A Pfeifer; S R Kurtz; C Johnson; W Johnson; R Johnston; D Sanders; R Karpman; G N Hallack; C R Valeri Journal: Clin Orthop Relat Res Date: 1994-02 Impact factor: 4.176