title: Determination of the efficacy of EVICEL™ on blood loss in orthopaedic surgery after total knee replacement: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  After total knee replacement, overall blood loss is often underestimated, although it exceeds the visible blood loss caused by bleeding into the tissues or into the joint. The use of fibrin sealants during surgery has been suggested to reduce perioperative blood loss and transfusion rates and may be beneficial for patient recovery and the postoperative function of the joint.
  
  
  METHODS
  This will be a single-centre, single-blinded, randomised controlled trial with a parallel design, for which 68 patients undergoing total knee replacement will be recruited and followed up at 3, 6 and 12 months; 34 will be control patients who will receive the standard orthopaedic surgery treatment (electrocoagulation), and the other 34 will receive the same treatment plus 5 ml EVICEL™ applied during surgery and used according to the manufacturer's instructions. The primary objective is to test the null hypothesis that the effect of EVICEL™ for controlling haemostasis and reducing postoperative blood loss in patients undergoing total knee replacement is not superior to the use of electrocoagulation alone. The secondary objective is to show that EVICEL™ reduces the need for transfusion, increases range of motion, improves clinical outcome and wound healing, and reduces the need for analgesics. The tertiary objective is to show that EVICEL™ reduces the costs of total knee replacement treatment.
  
  
  CONCLUSIONS
  So far, studies on the effect of fibrin sealants in total knee replacement have delivered inconsistent and ambivalent results, indicating that there is still a need for high-evidence studies as proposed in the presented study protocol.
  
  
  BACKGROUND
  German registration number DRKS00007564; date of registration: 26 November 2014.
authors.affiliation: Department of Orthopaedic Surgery, Hannover Medical School, Anna-von-Borries-Str. 1-7, 30625, Hannover, Germany. stefan.budde@ddh-gruppe.de.
authors.forename: S
authors.initials: S
authors.lastname: Budde
authors.affiliation: Department of Orthopaedic Surgery, Hannover Medical School, Anna-von-Borries-Str. 1-7, 30625, Hannover, Germany. yvonne.noll@ddh-gruppe.de.
authors.forename: Y
authors.initials: Y
authors.lastname: Noll
authors.affiliation: Hannover Clinical Trial Center GmbH, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. zieglschmid@clinical-trial-center.de.
authors.forename: V
authors.initials: V
authors.lastname: Zieglschmid
authors.affiliation: Institute of Clinical Pharmacology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. Schroeder.christoph@mh-hannover.de.
authors.forename: C
authors.initials: C
authors.lastname: Schroeder
authors.affiliation: Institute of Biometry, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. koch.armin@mh-hannover.de.
authors.forename: A
authors.initials: A
authors.lastname: Koch
authors.affiliation: Department of Orthopaedic Surgery, Hannover Medical School, Anna-von-Borries-Str. 1-7, 30625, Hannover, Germany. henning.windhagen@ddh-gruppe.de.
authors.forename: H
authors.initials: H
authors.lastname: Windhagen
mesh_terms: D000368:Aged; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects / Q000191:economics; D001696:Biomechanical Phenomena; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D001803:Blood Transfusion; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D004564:Electrocoagulation; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D005858:Germany; D006490:Hemostatics / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D017721:Hospital Costs; D006801:Humans; D007719:Knee Joint / Q000503:physiopathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000191:economics / Q000209:etiology / Q000517:prevention & control*; D016059:Range of Motion, Articular; D020127:Recovery of Function; D012107:Research Design; D012307:Risk Factors; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
chemical_list: D015718:Fibrin Tissue Adhesive; D006490:Hemostatics