Topical Hemostatic Therapy in Surgery: Bridging the Knowledge and Practice Gap

Shander, Aryeh; Kaplan, Lewis J.; Harris, Michael T.; Gross, Irwin; Nagarsheth, Nimesh P.; Nemeth, Jeffrey; Ozawa, Sherri; Riley, Jeffrey B.; Ashton, Maria E.; Ferraris, Victor A.

doi:10.1016/j.jamcollsurg.2014.03.061

Cited by 38 publications

(34 citation statements)

References 100 publications

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Section: Current Status Of Raplixa For Improving Surgical Haemostasismentioning

confidence: 99%

“…The choice of agent for a bleeding event is influenced by a variety of product design features and clinical factors, including the type of surgical procedure, bleeding site and accessibility [2]. The surgeon's preference and experience with a particular product will also influence choice and, predictably, there is considerable variation in the clinical use of topical haemostatic agents [2]. Furthermore, practice guidelines provide few specific recommendations for mild or moderate intraoperative bleeding, suggesting only that topical haemostats be administered for the control of excessive bleeding or bleeding that cannot be controlled by standard surgical techniques [2,11].…”

Section: Current Status Of Raplixa For Improving Surgical Haemostasismentioning

confidence: 99%

“…The surgeon's preference and experience with a particular product will also influence choice and, predictably, there is considerable variation in the clinical use of topical haemostatic agents [2]. Furthermore, practice guidelines provide few specific recommendations for mild or moderate intraoperative bleeding, suggesting only that topical haemostats be administered for the control of excessive bleeding or bleeding that cannot be controlled by standard surgical techniques [2,11]. The fibrin sealant category of topical haemostats contains products that combine high concentrations of human fibrinogen with human thrombin, which exert their effects at the final stage of the coagulation process (Sect.…”

Section: Current Status Of Raplixa For Improving Surgical Haemostasismentioning

confidence: 99%

“…3). While all fibrin sealants contain fibrinogen and thrombin as the two active components, they differ in several respects, including their composition, ease of use, efficacy and safety profile [2,3].…”

Section: Introductionmentioning

confidence: 99%

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Raplixa™: A Review in Improving Surgical Haemostasis

McKeage

2015

Clin Drug Investig

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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.

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Section: Current Status Of Raplixa For Improving Surgical Haemostasismentioning

confidence: 99%

Section: Current Status Of Raplixa For Improving Surgical Haemostasismentioning

confidence: 99%

Section: Current Status Of Raplixa For Improving Surgical Haemostasismentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Raplixa™: A Review in Improving Surgical Haemostasis

McKeage

2015

Clin Drug Investig

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“…1,2 The currently available adjuncts to hemostasis include: (1) mechanical hemostats such as gelatin or collagen sponges; (2) active hemostats, which contain thrombin; (3) flowables, which contain both a gelatin matrix and thrombin; and (4) fibrin sealants, which contain thrombin and fibrinogen, two of the main components needed to form a fibrin clot. 3,4 Fibrocaps (Raplixa; ProFibrix BV, Leiden, The Netherlands, a subsidiary of The Medicines Company) is a dry-powder, fibrin sealant that is being developed for control of surgical bleeding. Fibrocaps contains humanplasma-derived thrombin and fibrinogen.…”

mentioning

confidence: 99%