title: Intraarticular fibrinogen does not reduce blood loss in TKA: a randomized clinical trial.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors: Department of Orthopedics and Rheumatology, University Hospital Marburg, Marburg, Germany.
authors: Thomas Jan
authors: TJ
authors: Heyse
authors: Steven B
authors: SB
authors: Haas
authors: Denise
authors: D
authors: Drinkwater
authors: Stephen
authors: S
authors: Lyman
authors: Han Jo
authors: HJ
authors: Kim
authors: Barbara A
authors: BA
authors: Kahn
authors: Mark P
authors: MP
authors: Figgie
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019645:Arthroplasty, Replacement, Knee; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005340:Fibrinogen / Q000008:administration & dosage / Q000627:therapeutic use*; D006490:Hemostatics / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D006490:Hemostatics; D005340:Fibrinogen
references: Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001825
references: 17636687
references: J Bone Joint Surg Br. 2011 Dec;93(12):1577-85
references: 22161917
references: J Bone Joint Surg Am. 1991 Aug;73(7):1037-40
references: 1874765
references: J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9
references: 22623147
references: Br J Anaesth. 2003 May;90(5):596-9
references: 12697586
references: Transfusion. 1993 Jul;33(7):544-51
references: 8333017
references: Clin Orthop Relat Res. 1991 Aug;(269):98-101
references: 1864063
references: J Bone Joint Surg Br. 2004 May;86(4):561-5
references: 15174554
references: Transfusion. 2003 Apr;43(4):459-69
references: 12662278
references: J Bone Joint Surg Am. 2001 Oct;83(10):1503-5
references: 11679600
references: Int Orthop. 2001;25(1):22-4
references: 11374262
references: J Bone Joint Surg Br. 2012 Nov;94(11 Suppl A):8-10
references: 23118371
references: J Bone Joint Surg Am. 1999 Nov;81(11):1580-8
references: 10565650
references: J Bone Joint Surg Am. 1990 Aug;72(7):1010-2
references: 2384499
references: J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13
references: 21048170
references: J Bone Joint Surg Am. 1993 Sep;75(9):1356-7
references: 8408156
references: J Bone Joint Surg Am. 2012 Jul 3;94(13):1160-5
references: 22623075