A prospective, randomized, multicenter clinical trial on the safety and efficacy of a ready-to-use fibrin sealant as an adjunct to hemostasis during vascular surgery

Abstract Purpose Anastomotic or “stitch hole” bleeding is common during vascular surgery with synthetic material such as Dacron or polytetrafluoroethylene (PTFE). Hemostatic adjuncts such as fibrin sealant (FS) may reduce blood loss and operating time in such circumstances. We evaluated the safety and the hemostatic effectiveness of a ready-to-use human plasma-derived FS in vascular surgery. Methods Patients with mild / moderate suture line bleeding during elective, open, vascular surgery using synthetic grafts or patches were studied. In an initial Exploratory Study all patients were treated with FS Grifols, and in a subsequent Primary Study were randomized in a 2:1 ratio to FS Grifols or manual compression (MC). The primary efficacy endpoint was time to hemostasis (TTH), assessed at defined intervals from the start of treatment application, during a 10-minute observational period. Safety endpoints (in Exploratory+Primary Studies) included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests (coagulation; complete blood count; serum clinical chemistry parameters; microscopic urinalysis), viral markers, and immunogenicity. Results In the Primary Study the proportion of patients who achieved hemostasis at the 3 minute time point was higher in FS Grifols group (46.4%; n=51/110) than in MC group (26.3%; n=15/57) (P