Literature DB >> 26142085

Raplixa™: A Review in Improving Surgical Haemostasis.

Kate McKeage1.   

Abstract

Raplixa™ is a novel fibrin sealant containing a blend of human fibrinogen and thrombin in powder form. It is approved in adults to help control bleeding when standard surgical techniques have been insufficient. This article summarizes the product characteristics of Raplixa and provides a narrative review of its clinical use and tolerability. Unlike other available fibrin sealants, including liquid agents and lyophilized powders, the dry-powder, ready-to-use formulation of Raplixa provides potential advantages, including ease of storage and use. In the randomized, phase III FINISH-3 study, Raplixa plus gelatin sponge was superior to gelatin sponge alone in reducing the time to haemostasis in adults who developed mild or moderate bleeding uncontrolled by conventional surgical techniques while undergoing spinal, vascular, hepatic or soft-tissue surgical procedures. Raplixa was well tolerated, with a similar safety profile to that observed in the gelatin-sponge-alone group. Thus, Raplixa provides an easy to store and use option for improving haemostasis in adults when standard surgical techniques are ineffective or impractical.

Entities:  

Mesh:

Substances:

Year:  2015        PMID: 26142085     DOI: 10.1007/s40261-015-0307-5

Source DB:  PubMed          Journal:  Clin Drug Investig        ISSN: 1173-2563            Impact factor:   2.859


  8 in total

Review 1.  Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*.

Authors: 
Journal:  Anesthesiology       Date:  2015-02       Impact factor: 7.892

Review 2.  New fundamentals in hemostasis.

Authors:  Henri H Versteeg; Johan W M Heemskerk; Marcel Levi; Pieter H Reitsma
Journal:  Physiol Rev       Date:  2013-01       Impact factor: 37.312

Review 3.  An essential primer for understanding the role of topical hemostats, surgical sealants, and adhesives for maintaining hemostasis.

Authors:  Michael Gabay; Bradley A Boucher
Journal:  Pharmacotherapy       Date:  2013-05-17       Impact factor: 4.705

Review 4.  Topical hemostatic therapy in surgery: bridging the knowledge and practice gap.

Authors:  Aryeh Shander; Lewis J Kaplan; Michael T Harris; Irwin Gross; Nimesh P Nagarsheth; Jeffrey Nemeth; Sherri Ozawa; Jeffrey B Riley; Maria Ashton; Victor A Ferraris
Journal:  J Am Coll Surg       Date:  2014-06-02       Impact factor: 6.113

5.  Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials.

Authors:  Cornelis Verhoef; Neil Singla; Greg Moneta; William Muir; Arjen Rijken; Harry Lockstadt; Johannes H W de Wilt; Albert O-Yurvati; Linda A Zuckerman; Paul Frohna; Robert J Porte
Journal:  J Surg Res       Date:  2014-12-10       Impact factor: 2.192

6.  The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis.

Authors:  Grant V Bochicchio; Navyash Gupta; Robert J Porte; Kenneth L Renkens; Piet Pattyn; Baki Topal; Roberto Ivan Troisi; William Muir; Ian Chetter; Daniel L Gillen; Linda A Zuckerman; Paul A Frohna
Journal:  J Am Coll Surg       Date:  2014-10-13       Impact factor: 6.113

7.  Safety and efficacy of a novel, dry powder fibrin sealant for hemostasis in hepatic resection.

Authors:  Karin Ruitenbeek; N Ayez; C Verhoef; J Hans W de Wilt; Jan Bottema; Arjen M Rijken; Monique van Rij; Jaap Koopman; Linda A Zuckerman; Paul Frohna; Robert J Porte
Journal:  Dig Surg       Date:  2015-01-14       Impact factor: 2.588

Review 8.  Fibrin Sealant: The Only Approved Hemostat, Sealant, and Adhesive-a Laboratory and Clinical Perspective.

Authors:  William D Spotnitz
Journal:  ISRN Surg       Date:  2014-03-04
  8 in total
  2 in total

1.  Manufacturing strategies to develop amorphous solid dispersions: An overview.

Authors:  Nicole Mendonsa; Bjad Almutairy; Venkata Raman Kallakunta; Sandeep Sarabu; Priyanka Thipsay; Suresh Bandari; Michael A Repka
Journal:  J Drug Deliv Sci Technol       Date:  2019-12-11       Impact factor: 3.981

Review 2.  Pharmaceutical protein solids: Drying technology, solid-state characterization and stability.

Authors:  Yuan Chen; Tarun Tejasvi Mutukuri; Nathan E Wilson; Qi Tony Zhou
Journal:  Adv Drug Deliv Rev       Date:  2021-03-08       Impact factor: 15.470

  2 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.