Abstract
BackgroundTopical haemostatic agents are used to help achieve haemostasis during surgery when standard surgical techniques are insufficient. The objective of this study was to confirm the safety profile of an equine collagen patch coated with human fibrinogen and human thrombin with particular focus on the occurrence of thromboembolic events (TEEs), major bleeding and immunological events.MethodsThis was a non-interventional, multicentre, prospective, surveillance study in which a collagen fleece-bound fibrin sealant was prescribed in accordance with its marketing authorisation. The decision to use the sealant was based solely on current surgical practice. All patients that received the sealant and provided informed consent were included. TEEs (any coagula-based occlusion in a vessel or the heart identified by symptomatic clinical signs and/or verified by paraclinical examination), major bleeding (any bleeding that required intervention), and immunological events (hypersensitivity including anaphylaxis) that occurred during surgery, post-operative hospital stay or 6 months of follow-up were reported as adverse events. The primary endpoint was the proportion of patients experiencing a confirmed TEE.ResultsA total of 3098 patients were recruited at 227 centres in 12 European countries. The most frequent types of surgery were hepatic (33%), gastrointestinal (16%) and urological (14%) and the main indication for surgery was for primary (35%) or secondary (20%) malignancy. Forty-six patients (1.5%, 95% CI 1.1–2.0%) had at least one TEE during the study. The most commonly reported TEEs were pulmonary embolism or post-procedural pulmonary embolism (n = 18) and deep vein thrombosis (n = 9). There were 64 major bleedings in 62 patients and 9 immunological events in 8 patients.ConclusionCollagen fleece-bound fibrin sealant does not appear to be associated with an increased risk of TEEs, major bleeding or immunological events in patients undergoing surgery.Trial registrationClinicaltrials.gov number: NCT00285623
Highlights
Topical haemostatic agents are used to help achieve haemostasis during surgery when standard surgical techniques are insufficient
TachoSil® is a sterile, absorbable, haemostatic agent that consists of an equine collagen patch coated on one side with human fibrinogen and human thrombin
The possible role of drug interactions in thromboembolic events (TEEs) and major bleeding was investigated. This international, multicentre, prospective, surveillance study was of a non-interventional design, meaning that TachoSil was prescribed in accordance with the terms of its marketing authorisation
Summary
Topical haemostatic agents are used to help achieve haemostasis during surgery when standard surgical techniques are insufficient. Over the past 20 years, a wide variety of topical haemostatic agents such as fleeces of different origin (collagen-based, e.g. Avitene®; gelatine-based, e.g. Surgifoam®, Gelfoam®; regenerated oxidised cellulose-based, e.g. Surgicel®, Curacel®), liquid fibrin sealants (e.g. Tisseel®, Tissucol®, Evicel®, Beriplast®), albumin and glutaraldehyde bioglue (BioGlue®) and synthetic glues (e.g. CoSeal®) have increasingly been used in a range of surgical procedures to help achieve haemostasis when standard surgical techniques are insufficient [1,2,3] The use of these agents has a beneficial effect on surgical outcomes, including improved haemostasis, fewer complications and reduced duration of post-operative hospital stay [1,2]. TachoSil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient
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