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

S Budde,V Zieglschmid,H Windhagen,C Schroeder,Y Noll,A Koch

doi:10.1186/s13063-015-0822-y

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.

Highlights

After total knee replacement, overall blood loss is often underestimated, it exceeds the visible blood loss caused by bleeding into the tissues or into the joint
Bearing in mind that a new orthopaedic surgery guideline was published recently recommending that acetylsalicylic acid or clopidogrel regimens in patients undergoing orthopaedic surgery not be reduced or interrupted [3], the use of EVICELTM in daily clinical practice might contribute to a reduction of blood loss, especially in these patients
The primary objective is to test the null hypothesis that the effect of EVICELTM on controlling haemostasis and reducing postoperative blood loss in patients undergoing total knee replacement (TKR) is no different than with the use of standard orthopaedic surgery

Summary

Discussion

The clinical significance of and rationale for the conception of this study was the fact that after TKR only the ‘visible’ blood loss is usually known, whereas ‘hidden’ blood loss often is underestimated. In another study [15], the results suggested that transfusion rates in anaemic patients undergoing TKR were significantly lower than in a control group, and that the use of EVICEL resulted in a significant reduction of blood loss. A literature search delivers inconsistent and ambivalent results indicating that, despite the presence of comparable studies, there is still a need for highevidence studies clarifying the role of fibrin sealants in TKR, as proposed in the study protocol presented here. Trial status This RCT was designed as an investigator-initiated study for which Hannover Medical School was assumed to be acting as sponsor.

Background

Methods/Design

Procedures

Findings