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Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study
Jessica Shen; Jonathan Batiller; Sara Horn; James C Hart; Ofer Nativ; Bababhai Patel
BMC Nephrology,13,1(2012-11-08)
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摘要:

Background

Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages.

Methods

We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product???fibrin pad???to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N???=???10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N???=???7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10???min following randomization, analyzed by Fisher exact tests at 5% significance level.

Results

Phase I (N???=???10): All patients completed the study. Hemostasis was achieved within 3???4???min (average???=???3.1???min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N???=???7): Hemostatic success at 10???min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled.

Conclusions

The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage.

Trial registration

Phase I/II trial, NCT00598130

关键词:Nephron-sparing surgery, Hemostasis, Fibrin pad, Fibrinogen, Thrombin, Polyglactin 910, Oxidized-regenerated cellulose

出版者:BioMed Central Ltd
出版日期:2012-11-08
资源类型:期刊论文
学科分类:Urology;Nephrology
语种:en
授权许可:http://creativecommons.org/licenses/by/2.0/
本地全文:http://gooa.las.ac.cn/external/index?type=-1&pid=1083064
内容提供者:开放获取论文一站式发现平台(GoOA)

推荐引用方式:Jessica Shen,Jonathan Batiller,Sara Horn, et al. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study[J]. BMC Nephrology,2012,13(1)

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