Fibrin Sealant (Evicel® [Quixil®/Crosseal™])

Abstract

Evicel® is a fibrin sealant consisting of two components, human clottable protein (predominantly human fibrinogen) and human thrombin. It is indicated as supportive treatment in patients undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical. Evicel® is a new formulation of the previously available fibrin sealant Quixil® (in the EU) or Crosseal™ (in the US). Evicel® differs from Quixil®/Crosseal™ in that its fibrinogen component does not contain the antifibrinolytic agent tranexamic acid, which is potentially neurotoxic, resulting in Quixil®/Crosseal™ being contraindicated for use in neurosurgery. The removal of tranexamic acid did not affect the haemostatic efficacy or longevity of Evicel® fibrin clots and allowed the sealant to be granted an expanded indication. Evicel® and Quixil®/Crosseal™ are easy to use and, since they do not contain synthetic or bovine aprotinin, have a reduced potential for hypersensitivity reactions. This article reviews the pharmacological properties, clinical efficacy and tolerability of Evicel® and its previous formulation as supportive treatment for haemostasis in surgery. In clinical studies, Evicel® and Quixil®/Crosseal™ were generally well tolerated and effective haemostatic agents for adjunctive use in various types of surgeries when conventional methods were impractical or ineffective in controlling bleeding. Two pivotal, randomized studies showed that Evicel® was significantly more effective than manual compression in patients undergoing vascular surgery, and significantly more effective than Surgicel® in patients undergoing retroperitoneal or intra-abdominal surgery, as assessed by the proportion of patients achieving haemostasis. In another similarly designed pivotal study in patients undergoing liver resection, Crosseal™ was significantly more effective than standard haemostatic agents (e.g. Surgicel®), as assessed by the mean time to haemostasis. The incidences of treatment-emergent adverse events in these studies were generally similar between the Evicel® or Crosseal™ groups and the comparator groups. Quixil® was also generally well tolerated and an effective haemostatic agent in endonasal surgeries, and tonsillectomies and/or adenoidectomies, with some benefit of treatment with Evicel® or Quixil® also observed in orthopaedic surgeries. Although additional comparative studies with other haemostatic agents would help to definitively position Evicel® with respect to these agents, current evidence suggests that Evicel® is useful in surgeries for improving haemostasis where standard surgical techniques are insufficient.