Abstract

This is a prospective, randomized, active-controlled, single-blind, parallel group clinical trial to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during surgery in pediatric subjects. Pediatric subjects (<18 years of age requiring an elective non-emergent open non-laparoscopic pelvic abdominal or thoracic non-cardiac surgical procedure wherein a target bleeding site tbs is identified and a topical hemostatic agent is indicated will be eligible to participate in the clinical trial. the study treatments will be applied on the cut parenchymous surface of a solid organ ie liver and in soft tissue ie fat muscle or connective tissue.>

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