A randomized, controlled trial of Veriset™ hemostatic patch in halting cardiovascular bleeding

Obtaining hemostasis during cardiovascular procedures can be a challenge, particularly around areas with a complex geometry or that are difficult to access. While several topical hemostats are currently on the market, most have caveats that limit their use in certain clinical scenarios such as pulsa...

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Bibliographic Details
Published in:Medical devices (Auckland, N.Z.) N.Z.), 2018-01, Vol.11, p.65-75
Main Authors: Glineur, David, Hendrikx, Marc, Krievins, Dainis, Stradins, Peteris, Voss, Bernhard, Waldow, Thomas, Haenen, Luc, Oberhoffer, Martin, Ritchie, Caroline M
Format: Article
Language:English
Subjects:
Anaphylaxis
aortic valve replacement
CABG
Cardiac patients
cardiac surgery
Care and treatment
Clinical trials
Coronary vessels
Enrollments
Ethics
Heart surgery
Heart valve diseases
Hemostatic agents
Hospitals
Original Research
Patient safety
Polyethylene glycol
Sealing compounds
Software patches
Surgery
surgical bleeding
Thoracic surgery
Vascular surgery
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Summary:Obtaining hemostasis during cardiovascular procedures can be a challenge, particularly around areas with a complex geometry or that are difficult to access. While several topical hemostats are currently on the market, most have caveats that limit their use in certain clinical scenarios such as pulsatile arterial bleeding. The aim of this study was to assess the effectiveness and safety of Veriset™ hemostatic patch in treating cardiovascular bleeding. Patients (N=90) scheduled for cardiac or vascular surgery at 12 European institutions were randomized 1:1 to treatment with either Veriset™ hemostatic patch (investigational device) or TachoSil (control). After application of the hemostat, according to manufacturer instructions for use, time to hemostasis was monitored. Follow-up occurred up to 90 days post-surgery. Median time to hemostasis was 1.5 min with Veriset™ hemostatic patch, compared to 3.0 min with TachoSil (
ISSN:1179-1470
1179-1470
DOI:10.2147/MDER.S145651