Determination of the efficacy of EVICEL™ on blood loss in orthopaedic surgery after total knee replacement: study protocol for a randomised controlled trial

Abstract

BackgroundAfter 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/DesignThis 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.DiscussionSo 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.Trial registrationGerman registration number DRKS00007564; date of registration: 26 November 2014.

Blood loss and knee function after unicompartment knee arthroplasty(UKA) without tourniquet

“…However,it is still unclear that if HBL would compromise postoperative knee function. Budde et al found better knee function in patients with less intra-and postoperative blood loss [22]. They compared 34 patients undergoing standard TKA with 34 patients receiving a kind of hemostatic after TKA, and found a better function outcome in the hemostatic group.…”

Topical Fibrin Sealant (Tisseel@) Does Not Provide a Synergic Blood-Conservation Effect with Tranexamic Acid in Total Knee Arthroplasty—A Prospective Randomized Controlled Trial

“…Since 1972, the adjunctive use of fibrin sealants in certain surgical procedures has been adopted as an optional approach to manage hemostasis and minimize blood loss after surgical interventions. Nevertheless, the efficacy of fibrin sealants in TKA surgery has not yet attained the status of a standard practice [12]. Review articles and meta-analysis reports have indicated that high-dosage fibrin sealant is effective and safe as a hemostatic therapy for patients undergoing TKA [13][14][15].…”