Skip to main content
Top
Published in: Knee Surgery, Sports Traumatology, Arthroscopy 11/2015

01-11-2015 | Knee

Does a thrombin-based topical haemostatic agent reduce blood loss and transfusion requirements after total knee revision surgery? A randomized, controlled trial

Authors: Carlo L. Romanò, Lorenzo Monti, Nicola Logoluso, Delia Romanò, Lorenzo Drago

Published in: Knee Surgery, Sports Traumatology, Arthroscopy | Issue 11/2015

Login to get access

Abstract

Purpose

The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery.

Methods

This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient’s group allocation.

Results

Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 ± 1.13 (range 0–4) vs. 1.9 ± 1.41 (range 0–5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study.

Conclusions

This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery.

Clinical relevance

A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery.

Level of evidence

II.
Literature
1.
go back to reference Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM (2011) Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br 93(12):1577–1585CrossRefPubMed Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM (2011) Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br 93(12):1577–1585CrossRefPubMed
3.
go back to reference Berman AT, Geissele AE, Bosacco SJ (1988) Blood loss with total knee arthroplasty. Clin Orthop Relat Res 234:137–138PubMed Berman AT, Geissele AE, Bosacco SJ (1988) Blood loss with total knee arthroplasty. Clin Orthop Relat Res 234:137–138PubMed
4.
go back to reference Callaghan JJ, Spitzer AI (2000) Blood management and patient specific transfusion options in total joint replacement surgery. Iowa Orthop J 20:36–45PubMedCentralPubMed Callaghan JJ, Spitzer AI (2000) Blood management and patient specific transfusion options in total joint replacement surgery. Iowa Orthop J 20:36–45PubMedCentralPubMed
5.
go back to reference Clapp B, Santillan A (2011) Small bowel obstruction after FloSeal use. J Soc Laparoendosc Surg 15(3):361–364CrossRef Clapp B, Santillan A (2011) Small bowel obstruction after FloSeal use. J Soc Laparoendosc Surg 15(3):361–364CrossRef
6.
go back to reference Comadoll JL, Comadoll S, Hutchcraft A, Krishnan S, Farrell K, Kreuwel HT, Bechter M (2012) Comparison of hemostatic matrix and standard hemostasis in patients undergoing primary TKA. Orthopedics 35(6):e785–e793CrossRefPubMed Comadoll JL, Comadoll S, Hutchcraft A, Krishnan S, Farrell K, Kreuwel HT, Bechter M (2012) Comparison of hemostatic matrix and standard hemostasis in patients undergoing primary TKA. Orthopedics 35(6):e785–e793CrossRefPubMed
7.
go back to reference Courtney J, Liebelt D, Nett MP, Cushner FD (2012) Blood loss and transfusion rates following patellofemoral arthroplasty. Orthop Clin North Am 43(5):e44–e47CrossRefPubMed Courtney J, Liebelt D, Nett MP, Cushner FD (2012) Blood loss and transfusion rates following patellofemoral arthroplasty. Orthop Clin North Am 43(5):e44–e47CrossRefPubMed
8.
go back to reference Cuenca J, Garcia-Erce JA, Martinez F, Perez-Serrano L, Herrera A, Munoz M (2006) Perioperative intravenous iron, with or without erythropoietin, plus restrictive transfusion protocol reduce the need for allogeneic blood after knee replacement surgery. Transfusion 46(7):1112–1119CrossRefPubMed Cuenca J, Garcia-Erce JA, Martinez F, Perez-Serrano L, Herrera A, Munoz M (2006) Perioperative intravenous iron, with or without erythropoietin, plus restrictive transfusion protocol reduce the need for allogeneic blood after knee replacement surgery. Transfusion 46(7):1112–1119CrossRefPubMed
9.
go back to reference Di Francesco A, Flamini S, Fiori F, Mastri F (2013) Hemostatic matrix effects on blood loss after total knee arthroplasty: a randomized controlled trial. Indian J Orthop 47(5):474–481PubMedCentralCrossRefPubMed Di Francesco A, Flamini S, Fiori F, Mastri F (2013) Hemostatic matrix effects on blood loss after total knee arthroplasty: a randomized controlled trial. Indian J Orthop 47(5):474–481PubMedCentralCrossRefPubMed
10.
go back to reference Everts PA, Devilee RJ, Oosterbos CJ, Mahoney CB, Schattenkerk ME, Knape JT, van Zundert A (2007) Autologous platelet gel and fibrin sealant enhance the efficacy of total knee arthroplasty: improved range of motion, decreased length of stay and a reduced incidence of arthrofibrosis. Knee Surg Sports Traumatol Arthrosc 15(7):888–894CrossRefPubMed Everts PA, Devilee RJ, Oosterbos CJ, Mahoney CB, Schattenkerk ME, Knape JT, van Zundert A (2007) Autologous platelet gel and fibrin sealant enhance the efficacy of total knee arthroplasty: improved range of motion, decreased length of stay and a reduced incidence of arthrofibrosis. Knee Surg Sports Traumatol Arthrosc 15(7):888–894CrossRefPubMed
11.
go back to reference Juelsgaard P, Larsen UT, Sorensen JV, Madsen F, Soballe K (2001) Hypotensive epidural anesthesia in total knee replacement without tourniquet: reduced blood loss and transfusion. Reg Anesth Pain Med 26(2):105–110PubMed Juelsgaard P, Larsen UT, Sorensen JV, Madsen F, Soballe K (2001) Hypotensive epidural anesthesia in total knee replacement without tourniquet: reduced blood loss and transfusion. Reg Anesth Pain Med 26(2):105–110PubMed
12.
go back to reference Kim HJ, Fraser MR, Kahn B, Lyman S, Figgie MP (2012) The efficacy of a thrombin-based hemostatic agent in unilateral total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am 94(13):1160–1165CrossRefPubMed Kim HJ, Fraser MR, Kahn B, Lyman S, Figgie MP (2012) The efficacy of a thrombin-based hemostatic agent in unilateral total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am 94(13):1160–1165CrossRefPubMed
13.
go back to reference Kluba T, Fiedler K, Kunze B, Ipach I, Suckel A (2012) Fibrin sealants in orthopaedic surgery: practical experiences derived from use of QUIXIL® in total knee arthroplasty. Arch Orthop Trauma Surg 132(8):1147–1152CrossRefPubMed Kluba T, Fiedler K, Kunze B, Ipach I, Suckel A (2012) Fibrin sealants in orthopaedic surgery: practical experiences derived from use of QUIXIL® in total knee arthroplasty. Arch Orthop Trauma Surg 132(8):1147–1152CrossRefPubMed
14.
go back to reference Kurtz S, Ong K, Lau E, Mowat F, Halpern M (2007) Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am 89(4):780–785CrossRefPubMed Kurtz S, Ong K, Lau E, Mowat F, Halpern M (2007) Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am 89(4):780–785CrossRefPubMed
15.
go back to reference Kurtz SM, Ong KL, Lau E, Widmer M, Maravic M, Gomez-Barrena E, de Pina Mde F, Manno V, Torre M, Walter WL, de Steiger R, Geesink RG, Peltola M, Roder C (2011) International survey of primary and revision total knee replacement. Int Orthop 35(12):1783–1789PubMedCentralCrossRefPubMed Kurtz SM, Ong KL, Lau E, Widmer M, Maravic M, Gomez-Barrena E, de Pina Mde F, Manno V, Torre M, Walter WL, de Steiger R, Geesink RG, Peltola M, Roder C (2011) International survey of primary and revision total knee replacement. Int Orthop 35(12):1783–1789PubMedCentralCrossRefPubMed
16.
go back to reference Lavernia C, Lee DJ, Hernandez VH (2006) The increasing financial burden of knee revision surgery in the United States. Clin Orthop Relat Res 446:221–226CrossRefPubMed Lavernia C, Lee DJ, Hernandez VH (2006) The increasing financial burden of knee revision surgery in the United States. Clin Orthop Relat Res 446:221–226CrossRefPubMed
17.
go back to reference Liebelt DA, Levy BJ, Kadimcherla PK, Krystal JD, Li R, Lall A, Blum YC, Hirsh DM, Kim SJL (2013) Effects of intraoperative use of the topical hemostatic matrix agent Floseal, in primary unilateral total knee arthroplasty. Curr Orthop Pract 24(5):509–512CrossRef Liebelt DA, Levy BJ, Kadimcherla PK, Krystal JD, Li R, Lall A, Blum YC, Hirsh DM, Kim SJL (2013) Effects of intraoperative use of the topical hemostatic matrix agent Floseal, in primary unilateral total knee arthroplasty. Curr Orthop Pract 24(5):509–512CrossRef
18.
go back to reference Manifold SG, Cushner FD, Craig-Scott S, Scott WN (2000) Long-term results of total knee arthroplasty after the use of soft tissue expanders. Clin Orthop Relat Res 380:133–139CrossRefPubMed Manifold SG, Cushner FD, Craig-Scott S, Scott WN (2000) Long-term results of total knee arthroplasty after the use of soft tissue expanders. Clin Orthop Relat Res 380:133–139CrossRefPubMed
19.
go back to reference Massin P, Scemama C, Jeanrot C, Boyer P (2012) Does fibrin sealant use in total knee replacement reduce transfusion rates? A non-randomised comparative study. OTSR 98(2):180–185PubMed Massin P, Scemama C, Jeanrot C, Boyer P (2012) Does fibrin sealant use in total knee replacement reduce transfusion rates? A non-randomised comparative study. OTSR 98(2):180–185PubMed
20.
go back to reference Mesa-Ramos F, Mesa-Ramos M, Maquieira-Canosa C, Carpintero P (2008) Predictors for blood transfusion following total knee arthroplasty: a prospective randomised study. Acta Orthop Belg 74(1):83–89PubMed Mesa-Ramos F, Mesa-Ramos M, Maquieira-Canosa C, Carpintero P (2008) Predictors for blood transfusion following total knee arthroplasty: a prospective randomised study. Acta Orthop Belg 74(1):83–89PubMed
21.
go back to reference Mozet C, Prettin C, Dietze M, Fickweiler U, Dietz A (2012) Use of Floseal and effects on wound healing and pain in adults undergoing tonsillectomy: randomised comparison versus electrocautery. Eur Arch Otorhinolaryngol 269(10):2247–2254CrossRefPubMed Mozet C, Prettin C, Dietze M, Fickweiler U, Dietz A (2012) Use of Floseal and effects on wound healing and pain in adults undergoing tonsillectomy: randomised comparison versus electrocautery. Eur Arch Otorhinolaryngol 269(10):2247–2254CrossRefPubMed
22.
go back to reference Murphy MF, Wallington TB, Kelsey P, Boulton F, Bruce M, Cohen H, Duguid J, Knowles SM, Poole G, Williamson LM (2001) Guidelines for the clinical use of red cell transfusions. Br J Haematol 113(1):24–31CrossRefPubMed Murphy MF, Wallington TB, Kelsey P, Boulton F, Bruce M, Cohen H, Duguid J, Knowles SM, Poole G, Williamson LM (2001) Guidelines for the clinical use of red cell transfusions. Br J Haematol 113(1):24–31CrossRefPubMed
23.
go back to reference Nasso G, Piancone F, Bonifazi R, Romano V, Visicchio G, De Filippo CM, Impiombato B, Fiore F, Bartolomucci F, Alessandrini F, Speziale G (2009) Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg 88(5):1520–1526CrossRefPubMed Nasso G, Piancone F, Bonifazi R, Romano V, Visicchio G, De Filippo CM, Impiombato B, Fiore F, Bartolomucci F, Alessandrini F, Speziale G (2009) Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg 88(5):1520–1526CrossRefPubMed
24.
go back to reference Notarnicola A, Moretti L, Martucci A, Spinarelli A, Tafuri S, Pesce V, Moretti B (2012) Comparative efficacy of different doses of fibrin sealant to reduce bleeding after total knee arthroplasty. Blood Coagul Fibrinolysis 23(4):278–284CrossRefPubMed Notarnicola A, Moretti L, Martucci A, Spinarelli A, Tafuri S, Pesce V, Moretti B (2012) Comparative efficacy of different doses of fibrin sealant to reduce bleeding after total knee arthroplasty. Blood Coagul Fibrinolysis 23(4):278–284CrossRefPubMed
25.
go back to reference Ong KL, Mowat FS, Chan N, Lau E, Halpern MT, Kurtz SM (2006) Economic burden of revision hip and knee arthroplasty in Medicare enrollees. Clin Orthop Relat Res 446:22–28CrossRefPubMed Ong KL, Mowat FS, Chan N, Lau E, Halpern MT, Kurtz SM (2006) Economic burden of revision hip and knee arthroplasty in Medicare enrollees. Clin Orthop Relat Res 446:22–28CrossRefPubMed
26.
go back to reference Parker MJ, Livingstone V, Clifton R, McKee A (2007) Closed suction surgical wound drainage after orthopaedic surgery. Cochrane Database Syst Rev 3: CD001825 Parker MJ, Livingstone V, Clifton R, McKee A (2007) Closed suction surgical wound drainage after orthopaedic surgery. Cochrane Database Syst Rev 3: CD001825
27.
go back to reference Renkens KL Jr, Payner TD, Leipzig TJ, Feuer H, Morone MA, Koers JM, Lawson KJ, Lentz R, Shuey H Jr, Conaway GL, Andersson GB, An HS, Hickey M, Rondinone JF, Shargill NS (2001) A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine (Phila Pa 1976) 26(15):1645–1650CrossRef Renkens KL Jr, Payner TD, Leipzig TJ, Feuer H, Morone MA, Koers JM, Lawson KJ, Lentz R, Shuey H Jr, Conaway GL, Andersson GB, An HS, Hickey M, Rondinone JF, Shargill NS (2001) A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery. Spine (Phila Pa 1976) 26(15):1645–1650CrossRef
28.
go back to reference Sabatini L, Trecci A, Imarisio D, Uslenghi MD, Bianco G, Scagnelli R (2012) Fibrin tissue adhesive reduces postoperative blood loss in total knee arthroplasty. J Orthop Traumatol 13(3):145–151PubMedCentralCrossRefPubMed Sabatini L, Trecci A, Imarisio D, Uslenghi MD, Bianco G, Scagnelli R (2012) Fibrin tissue adhesive reduces postoperative blood loss in total knee arthroplasty. J Orthop Traumatol 13(3):145–151PubMedCentralCrossRefPubMed
29.
go back to reference Seo JG, Moon YW, Park SH, Kim SM, Ko KR (2013) The comparative efficacies of intra-articular and IV tranexamic acid for reducing blood loss during total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 21(8):1869–187430CrossRefPubMed Seo JG, Moon YW, Park SH, Kim SM, Ko KR (2013) The comparative efficacies of intra-articular and IV tranexamic acid for reducing blood loss during total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 21(8):1869–187430CrossRefPubMed
30.
go back to reference Spence RK (1998) Anemia in the patient undergoing surgery and the transfusion decision. A review. Clin Orthop Relat Res 357:19–29CrossRefPubMed Spence RK (1998) Anemia in the patient undergoing surgery and the transfusion decision. A review. Clin Orthop Relat Res 357:19–29CrossRefPubMed
31.
go back to reference Weaver FA, Hood DB, Zatina M, Messina L, Badduke B (2002) Gelatin-thrombin-based hemostatic sealant for intraoperative bleeding in vascular surgery. Ann Vasc Surg 16(3):286–293CrossRefPubMed Weaver FA, Hood DB, Zatina M, Messina L, Badduke B (2002) Gelatin-thrombin-based hemostatic sealant for intraoperative bleeding in vascular surgery. Ann Vasc Surg 16(3):286–293CrossRefPubMed
32.
go back to reference Wille AH, Johannsen M, Miller K, Deger S (2009) Laparoscopic partial nephrectomy using FloSeal for hemostasis: technique and experiences in 102 patients. Surg Innov 16(4):306–312CrossRefPubMed Wille AH, Johannsen M, Miller K, Deger S (2009) Laparoscopic partial nephrectomy using FloSeal for hemostasis: technique and experiences in 102 patients. Surg Innov 16(4):306–312CrossRefPubMed
Metadata
Title
Does a thrombin-based topical haemostatic agent reduce blood loss and transfusion requirements after total knee revision surgery? A randomized, controlled trial
Authors
Carlo L. Romanò
Lorenzo Monti
Nicola Logoluso
Delia Romanò
Lorenzo Drago
Publication date
01-11-2015
Publisher
Springer Berlin Heidelberg
Published in
Knee Surgery, Sports Traumatology, Arthroscopy / Issue 11/2015
Print ISSN: 0942-2056
Electronic ISSN: 1433-7347
DOI
https://doi.org/10.1007/s00167-014-3153-8

Other articles of this Issue 11/2015

Knee Surgery, Sports Traumatology, Arthroscopy 11/2015 Go to the issue