BACKGROUND: Bleeding remains an ongoing concern after total knee arthroplasty (TKA). Intraarticular application of human fibrinogen with a topical thrombin has been described to stop diffuse bleeding in knee arthroplasty. QUESTIONS/PURPOSES: It was hypothesized that the use of human fibrinogen as a topical agent would result in a reduction of bleeding and transfusions required after TKA; secondary end points included comparison of early clinical results including pain scores and range of motion (ROM) at 6 weeks and complications after surgery. METHODS:Two hundred patients undergoing TKA were randomized into a double-blind clinical trial to receive either intraarticular fibrinogen 2 minutes before tourniquet release or no such treatment. Postoperative hemoglobin and hematocrit levels, drain output, and transfusion requirements were recorded and blood loss was calculated. Clinical outcomes and adverse events were tracked prospectively. Descriptive analysis was performed using a two-sample t-test. RESULTS: There were no differences in calculated blood loss between the fibrinogen and the control groups; the mean postoperative drain output was 780 ± 378 mL in the fibrinogen group compared with 673 ± 301 mL in the control group (p = 0.029), but the hemoglobin drop at Day 2 was 3.47 ± 1.53 g/L in the fibrinogen group and 3.84 ± 1.24 g/Ll in the control group (p = 0.051). There were no differences in in transfusions, early ROM, visual analog pain scores, or complications between the groups. CONCLUSIONS: The use of fibrinogen in TKA did not lead to a significant reduction of blood loss or transfusions in primary TKA for osteoarthritis. Given the lack of benefits and the costs this procedure adds to TKA, its routine use cannot be justified during primary TKA for osteoarthritis.
RCT Entities:
BACKGROUND:Bleeding remains an ongoing concern after total knee arthroplasty (TKA). Intraarticular application of humanfibrinogen with a topical thrombin has been described to stop diffuse bleeding in knee arthroplasty. QUESTIONS/PURPOSES: It was hypothesized that the use of humanfibrinogen as a topical agent would result in a reduction of bleeding and transfusions required after TKA; secondary end points included comparison of early clinical results including pain scores and range of motion (ROM) at 6 weeks and complications after surgery. METHODS: Two hundred patients undergoing TKA were randomized into a double-blind clinical trial to receive either intraarticular fibrinogen 2 minutes before tourniquet release or no such treatment. Postoperative hemoglobin and hematocrit levels, drain output, and transfusion requirements were recorded and blood loss was calculated. Clinical outcomes and adverse events were tracked prospectively. Descriptive analysis was performed using a two-sample t-test. RESULTS: There were no differences in calculated blood loss between the fibrinogen and the control groups; the mean postoperative drain output was 780 ± 378 mL in the fibrinogen group compared with 673 ± 301 mL in the control group (p = 0.029), but the hemoglobin drop at Day 2 was 3.47 ± 1.53 g/L in the fibrinogen group and 3.84 ± 1.24 g/Ll in the control group (p = 0.051). There were no differences in in transfusions, early ROM, visual analog pain scores, or complications between the groups. CONCLUSIONS: The use of fibrinogen in TKA did not lead to a significant reduction of blood loss or transfusions in primary TKA for osteoarthritis. Given the lack of benefits and the costs this procedure adds to TKA, its routine use cannot be justified during primary TKA for osteoarthritis.
Authors: Jean Wong; Amir Abrishami; Hossam El Beheiry; Nizar N Mahomed; J Roderick Davey; Rajiv Gandhi; Khalid A Syed; Syed Muhammad Ovais Hasan; Yoshani De Silva; Frances Chung Journal: J Bone Joint Surg Am Date: 2010-11-03 Impact factor: 5.284
Authors: Wiebe C Verra; Joost A van Hilten; Áine Honohan; Erik W van Zwet; Johanna G van der Bom; Rob G H H Nelissen Journal: PLoS One Date: 2018-07-25 Impact factor: 3.240