Aprotinin and classic wound drainage are unnecessary in total hip replacement a prospective randomized trial

European Journal of Medical Research

W Fleischmann⁶  E Bdlke⁶  M van Griensven⁴  M Schick⁶  M Peiper⁵  WT Knoefel⁵  R Mota²  PA Gerber²  K Orth¹  C Matuschek³  F Fleischmann⁶ 

[1] Department of Surgery, KRH Hannover, Germany;Department of Dermatology, University of Dusseldorf, Germany;Department of Radiation Therapy and Radiation Oncology, University of Dusseldorf, Germany;Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Research Center, Austrian Cluster for Tissue Regeneration, Vienna, Austria;Department of Surgery, University of Dusseldorf, Germany;Department of Surgery, Krankenhaus BietigheimBiesingen, Germany

关键词: compression treatment;    Trasylol^®;    aprotinin;    drug reaction;    wound drainage;    total hip replacement;   

Others  :  828548
DOI  :  10.1186/2047-783X-16-1-20

 received in 2010-10-14, accepted in 2010-10-22,  发布年份 2011

【 摘 要 】

Background

Classic wound drainage is still common in hip replacement but its benefit is doubtful. The role of systemic administration of proteinase inhibitors like aprotinin to avoid perioperative blood loss is still unclear.

Patients and Methods

In a prospective randomized trial, the perioperative blood loss in alloplastic hip replacement under the influence of proteinase inhibitor (aprotinin, Trasylol^®) using wound drainage as well as compression treatment alone were compared. 80 patients were prospectively randomized in 4 arms. Patients received either aprotinin or placebo during surgery as well as drainage or targeted external wound compression.

Results

Observing the "drug therapy" aprotinin had no effect on the intraor postoperative blood loss (p > 0.05), a trend to lower postoperative hemoglobin decline was found, but without significance. thrombosis occurred in neither the aprotinin nor in the placebo group. Two patients had a severe allergic drug reaction and were excluded from the study. Under "non drug therapy" with compression therapy and wound drainage a significant difference in blood loss was found (p < 0.001). The blood loss was higher under the wound drainage. There was no influence on the infection rate. Yet we could observe increased bruising under the sole external compression treatment.

Conclusion

The administration of aprotinin did not achieve the desired reduction of perioperative blood loss. Hence, costs and two severe allergic drug reactions in our study represent arguments against its use in regular treatment. Furthermore, it seems that wound drainage is neglectable in hip replacement and can be substituted by a sole compression treatment.

【 授权许可】

   
2011 I. Holzapfel Publishers

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

Figure 1.

Figure 5.

Figure 6.

Figure 1.

Figure 2.

Figure 3.

Figure 4.

Figure 5.

Figure 6.

【 参考文献 】

• [1]Augoustides JG: On-pump versus off-pump CABG. N Engl J Med 2010, 362:852. author reply 853-854
• [2]Avorn J: Dangerous deception--hiding the evidence of adverse drug effects. N Engl J Med 2006, 355:2169-2171.
• [3]Baubillier E, Cherqui D, Dominique C, Khalil M, Bonnet F, Fagniez PL, Duvaldestin P: A fatal thrombotic complication during liver transplantation after aprotinin administration. Transplantation 1994, 57:1664-1666.
• [4]Bidstrup BP, Royston D, Taylor KM, Sapsford RN: Effect of aprotinin on need for blood transfusion in patients with septic endocarditis having open-heart surgery. Lancet 1988, 1:366-367.
• [5]Bidstrup BP, Underwood SR, Sapsford RN, Streets EM: Effect of aprotinin (Trasylol) on aorta-coronary bypass graft patency. J Thorac Cardiovasc Surg 1993, 105:147-152. discussion 153
• [6]Bohrer H, Fleischer F, Lang J, Vahl C: Early formation of thrombi on pulmonary artery catheters in cardiac surgical patients receiving high-dose aprotinin. J Cardiothorac Anesth 1990, 4:222-225.
• [7]Browett JP, Gibbs AN, Copeland SA, Deliss LJ: The use of suction drainage in the operation of meniscectomy. J Bone Joint Surg Br 1978, 60-B:516-519.
• [8]Brown JR, Birkmeyer NJ, O'connor GT: Aprotinin in cardiac surgery. N Engl J Med 2006, 354:1953-1957. author reply 1953-1957
• [9]Brueggemann PM, Tucker JK, Wilson P: Intermittent clamping of suction drains in total hip replacement reduces postoperative blood loss: a randomized, controlled trial. J Arthroplasty 1999, 14:470-472.
• [10]Burri C: [Surgical suction drains. A comment on the paper by H. Lohfert (author's transl)]. Unfallheilkunde 1980, 83:377-379.
• [11]Capdevila X, Calvet Y, Biboulet P, Biron C, Rubenovitch J, D'athis F: Aprotinin decreases blood loss and homologous transfusions in patients undergoing major orthopedic surgery. Anesthesiology 1998, 88:50-57.
• [12]Cobb JP: Why use drains? J Bo'ne Joint Surg Br 1990, 72:993-995.
• [13]D'ambra MN: Aprotinin in cardiac surgery. N Engl J Med 2006, 354:1953-1957. author reply 1953-1957
• [14]Drazen JM: Research replication. N Engl J Med 2006, 355:2252-2253.
• [15]Esler CN, Blakeway C, Fiddian NJ: The use of a closed-suction drain in total knee arthroplasty. A prospective, randomised study. J Bone Joint Surg Br 2003, 85:215-217.
• [16]Fergusson DA, Hebert PC, Mazer CD, Fremes S, Macadams C, Murkin JM, Teoh K, Duke PC, Arellano R, Blajchman MA, Bussieres JS, Cote D, Karski J, Martineau R, Robblee JA, Rodger M, Wells G, Clinch J, Pretorius R: A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med 2008, 358:2319-2331.
• [17]Ferraris VA, Bridges CR, Anderson RP: Aprotinin in cardiac surgery. N Engl J Med 2006, 354:1953-1957. author reply 1953-1957
• [18]Gerngross H, Engler V: [Gravity drainage versus suction drainage: an experimental and clinical study]. Unfallchimrg 1989, 92:37-42.
• [19]Gerngross H, Marquardt KJ: [What suction drainage is optimal for drainage of wound secretion? A clinico-experimental study exemplified by the knee joint]. Chirurg 1992, 63:447-453.
• [20]Gerngross H, Willy C, Walter WM: [Experimental and clinical studies of the use of thin-lumen polyurethane gravity drainage in accident surgery]. Unfallchirurg 1992, 95:21-30.
• [21]Hallstrom BR, Steele JF: Postoperative course after total hip arthroplasty: wound drainage versus no drainage. Orthop Rev 1992, 21:847-851.
• [22]Hananouchi T, Saito M, Koyama T, Sugano N, Yoshikawa H: Tailor-made Surgical Guide Reduces Incidence of Outliers of Cup Placement. Clin Orthop Relat Res 468:1088-1095.
• [23]Harle A: [Postoperative wound suction drainage and its effect on wound healing]. Z Orthop Ihre Grenzgeb 1985, 123:395-402.
• [24]Harle A: [Weaknesses of conventional drainage systems]. Z Orthop Ihre Grenzgeb 1989, 127:513-517.
• [25]Harle A: [Wound drainage]. Hefte Unfallheilkd 1982, 158:491-501.
• [26]Harle A, Ritzerfeld WR, Linnenbaum FJ: [Bacterial studies of wound and drainage systems and their correlation with clinical findings]. Z Orthop Ihre Grenzgeb 1983, 121:584-592.
• [27]Hiatt WR: Observational studies of drug safety--aprotinin and the absence of transparency. N Engl J Med 2006, 355:2171-2173.
• [28]Holt BT, Parks NL, Engh GA, Lawrence JM: Comparison of closed-suction drainage and no drainage after primary total knee arthroplasty. Orthopedics 1997, 20:1121-1124. discussion 1124-1125
• [29]Jeserschek R, Clar H, Aigner C, Rehak P, Primus B, Windhager R: Reduction of blood loss using high-dose aprotinin in major orthopaedic surgery: a prospective, double-blind, randomised and placebo-controlled study. J Bone Joint Surg Br 2003, 85:174-177.
• [30]Kasper SM, Elsner F, Hilgers D, Grond S, Rutt J: A retrospective study of the effects of small-dose aprotinin on blood loss and transfusion needs during total hip arthroplasty. Eur J Anaesthesiol 1998, 15:669-675.
• [31]Kirschner P, Romer H, Werner HP: [Complications of Redon drainage following hip joint replacement operations--an analysis of the causes]. Unfallchirurgie 1989, 15:24-31.
• [32]Knapp U, Sander J, Vieweg K: [Bacteriological study of redon drains in accident surgery (author's transl)]. Dtsch Med Wochenschr 1975, 100:10-13.
• [33]Kumar PD: Prevention and treatment of major blood loss. N Engl J Med 2007, 357:1260-1261. author reply 1261
• [34]Labek G, Bohler N: [Blood transfusion in total hip endoprosthesis operations in relation to Redon drainage and pressure bandages. An innovation in surgical method]. Z Orthop Ihre Grenzgeb 1998, 136:433-438.
• [35]Langdown AJ, Field J, Grote J, Himayat H: Aprotinin (Trasylol) does not reduce bleeding in primary total hip arthroplasty. J Arthroplasty 2000, 15:1009-1012.
• [36]Levy JH, Ramsay JG, Guyton RA: Aprotinin in cardiac surgery. N Engl J Med 2006, 354:1953-1957. author reply 1953-1957
• [37]Mangano DT, Rieves RD, Weiss KD: Judging the safety of aprotinin. N Engl J Med 2006, 355:2261-2262.
• [38]Mangano DT, Tudor IC, Dietzel C: The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006, 354:353-365.
• [39]Murkin JM, Haig GM, Beer KJ, Cicutti N, Mccutchen J, Comunale ME, Hall R, Ruzicka BB: Aprotinin decreases exposure to allogeneic blood during primary unilateral total hip replacement. J Bone Joint Surg Am 2000, 82:675-684.
• [40]Murkin JM, Shannon NA, Bourne RB, Rorabeck CH, Cruickshank M, Wyile G: Aprotinin decreases blood loss in patients undergoing revision or bilateral total hip arthroplasty. Anesth Analg 1995, 80:343-348.
• [41]Myles PS: Aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med 2008, 359:1181. author reply 1181-1182
• [42]Neviaser AS, Chang C, Lyman S, Della Valle A, Haas SB: High incidence of complications from enoxaparin treatment after arthroplasty. Clin Orthop Re-lat Res 2010, 468:115-119.
• [43]Parker MJ, Roberts CP, Hay D: Closed suction drainage for hip and knee arthroplasty. A meta-analysis. J Bone Joint Surg Am 2004, 86-A:1146-1152.
• [44]Porte RJ, Mallette SV, Burroughs AK: Aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med 2008, 359:1181. author reply 1181-1182
• [45]Ray WA: Learning from aprotinin--mandatory trials of comparative efficacy and safety needed. N Engl J Med 2008, 358:840-842.
• [46]Ray WA, Stein CM: The aprotinin story--is BART the final chapter? N Engl J Med 2008, 358:2398-2400.
• [47]Reilly TJ, Gradisar IA Jr, Pakan W, Reilly M: The use of postoperative suction drainage in total knee arthroplasty. Clin Orthop Relat Res 1986, 238-242.
• [48]Rieves RD, Weiss KD: Judging the safety of aprotinin. N Engl J Med 2006, 355:2262.
• [49]Ritter MA, Keating EM, Faris PM: Closed wound drainage in total hip or total knee replacement. A prospective, randomized study. J Bone Joint Surg Am 1994, 76:35-38.
• [50]Royston D: High-dose aprotinin therapy: a review of the first five years' experience. J Cardiothorac Vasc Anesth 1992, 6:76-100.
• [51]Samama CM: A direct antifibrinolytic agent in major orthopedic surgery. Orthopedics 2004, 27:s675-680.
• [52]Samama CM, Langeron O, Rosencher N, Capdevila X, Rouche P, Pegoix M, Berniere J, Coriat P: Aprotinin versus placebo in major orthopedic surgery: a randomized, double-blinded, dose-ranging study. Anesth Analg 2002, 95:287-293. table of contents
• [53]Schneeweiss S, Seeger JD, Landon J, Walker AM: Aprotinin during coronary-artery bypass grafting and risk of death. N Engl J Med 2008, 358:771-783.
• [54]Shaw AD, Stafford-Smith M, White WD, Phillips-Bute B, Swaminathan M, Milano C, Welsby IJ, Aronson S, Mathew JP, Peterson ED, Newman MF: The effect of aprotinin on outcome after coronaryartery bypass grafting. N Engl J Med 2008, 358:784-793.
• [55]Tittel K, Hufnagel F, Schauwecker F: [Spiral drainage. An improved suction drainage]. Chirurg 1980, 51:185-186.
• [56]Van Haelst IM, Egberts TC, Doodeman HJ, Traast S, Burger BJ, Kalkman CJ, Van Klei WA: Use of serotonergic antidepressants and bleeding risk in orthopedic patients. Anesthesiology 2010, 112:631-636.
• [57]Vlahakes GJ: The value of phase 4 clinical testing. N Engl J Med 2006, 354:413-415.
• [58]Werner HP: [Complications and risks of suction drainage]. Z Gesamte Hyg 1990, 36:94-99.
• [59]Willett KM, Simmons CD, Bentley G: The effect of suction drains after total hip replacement. J Bone Joint Surg Br 1988, 70:607-610.
• [60]Wolter D, Burri C, Kinzl L, Muller A: [The change of physical properties of plastics (polyoxymethylenecopolymer, polyethyleneterephthalate, polyethylene, polytetrafluorethylene) after animal implantation and autoclavation (author's transl)]. Arch Orthop Unfallchir 1976, 86:291-302.
• [61]Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S: Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth 2010, 104:23-30.