The FINISH-3 Trial: A Phase 3, International, Randomized, Single-Blind, Controlled Trial of Topical Fibrocaps in Intraoperative Surgical Hemostasis

Bochicchio, Grant V.; Gupta, Navyash; Porte, Robert J.; Renkens, Kenneth L.; Pattyn, Piet; Topal, Baki; Troisi, Roberto; Muir, William W.; Chetter, Ian; Gillen, Daniel L.; Zuckerman, L; Frohna, Paul

doi:10.1016/j.jamcollsurg.2014.09.019

Cited by 26 publications

(47 citation statements)

References 15 publications

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“…The RCTs included in the meta-analysis reported fibrin use within four surgical specialties: cardiothoracic lung and heart, breast and axillary/inguinal lymph nodes, orthopaedics and neurosurgery. Patients receiving fibrin sealants had a statistically significant lower risk of reoperation than those in the control group (15 RCTs,60,77,85,86,93,101,107,116,125,135,138,140,143,237,239 n = 3789, OR 0.65, 95% CI 0.48 to 0.87; p ≤ 0.01; I 2 = 0%, fixed-effects model). The random-effects model showed a similar result (see Appendix 8).…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 97%

“…The random-effects models showed similar results (see Appendix 8). Reoperation A total of 20 RCTs reported reoperation as an outcome, of which 15 60,77,85,86,93,101,107,116,125,135,138,140,143,237,239 were included in the meta-analysis ( Figure 18). Five RCTs were excluded for the following reasons: Droghetti et al, 124 Milne et al 201 and Dimo et al 80 reported that none of the trial patients had a reoperation; Bulbuller et al 92 reported that the only patients who had a reoperation were in an additional intervention arm and not in the fibrin or standard care arms; and Moser et al…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

“…Furthermore, eight RCTs 78,107,108,151,153,221,239,250 only reported the number of patients with pain.…”

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confidence: 99%

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The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms

Edwards¹,

Crawford²,

Velthoven³

et al. 2016

Health Technol Assess

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BackgroundFibrin sealants are used in different types of surgery to prevent the accumulation of post-operative fluid (seroma) or blood (haematoma) or to arrest haemorrhage (bleeding). However, there is uncertainty around the benefits and harms of fibrin sealant use.ObjectivesTo systematically review the evidence on the benefits and harms of fibrin sealants in non-emergency surgery in adults.Data sourcesElectronic databases [MEDLINE, EMBASE and The Cochrane Library (including the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Health Technology Assessment database and the Cochrane Central Register of Controlled Trials)] were searched from inception to May 2015. The websites of regulatory bodies (the Medicines and Healthcare products Regulatory Agency, the European Medicines Agency and the Food and Drug Administration) were also searched to identify evidence of harms.Review methodsThis review included randomised controlled trials (RCTs) and observational studies using any type of fibrin sealant compared with standard care in non-emergency surgery in adults. The primary outcome was risk of developing seroma and haematoma. Only RCTs were used to inform clinical effectiveness and both RCTs and observational studies were used for the assessment of harms related to the use of fibrin sealant. Two reviewers independently screened all titles and abstracts to identify potentially relevant studies. Data extraction was undertaken by one reviewer and validated by a second. The quality of included studies was assessed independently by two reviewers using the Cochrane Collaboration risk-of-bias tool for RCTs and the Centre for Reviews and Dissemination guidance for adverse events for observational studies. A fixed-effects model was used for meta-analysis.ResultsWe included 186 RCTs and eight observational studies across 14 surgical specialties and five reports from the regulatory bodies. Most RCTs were judged to be at an unclear risk of bias. Adverse events were inappropriately reported in observational studies. Meta-analysis across non-emergency surgical specialties did not show a statistically significant difference in the risk of seroma for fibrin sealants versus standard care in 32 RCTs analysed [n = 3472, odds ratio (OR) 0.84, 95% confidence interval (CI) 0.68 to 1.04;p = 0.13;I2 = 12.7%], but a statistically significant benefit was found on haematoma development in 24 RCTs (n = 2403, OR 0.62, 95% CI 0.44 to 0.86;p = 0.01;I2 = 0%). Adverse events related to fibrin sealant use were reported in 10 RCTs and eight observational studies across surgical specialties, and 22 RCTs explicitly stated that there were no adverse events. One RCT reported a single death but no other study reported mortality or any serious adverse events. Five regulatory body reports noted death from air emboli associated with fibrin sprays.LimitationsIt was not possible to provide a detailed evaluation of individual RCTs in their specific contexts because of the limited resources that were available for this research. In addition, the number of RCTs that were identified made it impractical to conduct independent data extraction by two reviewers in the time available.ConclusionsThe effectiveness of fibrin sealants does not appear to vary according to surgical procedures with regard to reducing the risk of seroma or haematoma. Surgeons should note the potential risk of gas embolism if spray application of fibrin sealants is used and not to exceed the recommended pressure and spraying distance. Future research should be carried out in surgery specialties for which only limited data were found, including neurological, gynaecological, oral and maxillofacial, urology, colorectal and orthopaedics surgery (for any outcome); breast surgery and upper gastrointestinal (development of haematoma); and cardiothoracic heart or lung surgery (reoperation rates). In addition, studies need to use adequate sample sizes, to blind participants and outcome assessors, and to follow reporting guidelines.Study registrationThis study is registered as PROSPERO CRD42015020710.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Assessment Of Clinical Effectivenessmentioning

confidence: 97%

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

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The use of fibrin sealant during non-emergency surgery: a systematic review of evidence of benefits and harms

Edwards¹,

Crawford²,

Velthoven³

et al. 2016

Health Technol Assess

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“…One gram of Raplixa contains 79 mg fibrinogen and 699 IU thrombin [5]. The two components are individually purified, including viral clearance, then spray dried with a protective coating of trehalose (a naturally occurring plant sugar) to prevent thrombin from converting fibrinogen to fibrin causing clot formation within the vial [5,6]. The resulting free-flowing microparticles are then blended in a specific ratio to form a ready-to-use powder [5,6].…”

Section: Product Descriptionmentioning

confidence: 99%

“…In the phase II trials [one in the USA (n = 70) and one in the Netherlands (n = 56)], Raplixa plus gelatin sponge was more effective than gelatin sponge alone in the control of mild or moderate surgical bleeding (following spinal, vascular, hepatic, or soft tissue dissection procedures), with a significantly shorter mean TTH in Raplixa treatment groups [1.9 vs. 4.8 min in the US study (p \ 0.001) and 2.2 vs. 4.4 min in the Netherlands study (p = 0.004)] [10]. This section discusses the results of the large (n = 721) phase III trial [6].…”

Section: Clinical Efficacy Of Raplixamentioning

confidence: 99%

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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