PMID- 30926276 OWN - NLM STAT- MEDLINE DCOM- 20200527 LR - 20200527 IS - 1097-6809 (Electronic) IS - 0741-5214 (Linking) VI - 70 IP - 5 DP - 2019 Nov TI - A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery. PG - 1642-1651 LID - S0741-5214(19)30214-9 [pii] LID - 10.1016/j.jvs.2018.12.051 [doi] AB - OBJECTIVE: New formulations and applications of hemostatic adjuncts such as fibrin sealant (FS) to support local hemostasis and sutures continue to be developed. In a pivotal, confirmatory, controlled, prospective, single-blinded, randomized, multicenter phase III clinical trial, the efficacy and safety of FS Grifols during vascular surgeries were evaluated. METHODS: Patients undergoing a nonemergency, open, peripheral vascular surgical procedure with moderate arterial bleeding were recruited. In an initial preliminary part of the study, all patients were treated with FS Grifols. In a subsequent primary part, patients were randomized (2:1) to FS Grifols or manual compression (MC). The primary efficacy end point was the proportion of the primary part patients achieving hemostasis by 4 minutes after the start of treatment. Cumulative proportion and time to hemostasis were secondary efficacy end points. Safety end points (in pooled preliminary and primary parts) included adverse events (AEs), vital signs, physical assessments, clinical laboratory tests, viral markers, and immunogenicity. RESULTS: The primary efficacy end point was met by 76.1% of patients (83/109) for the FS Grifols group versus 22.8% of patients (13/57) for the MC group (P < .001). The cumulative proportion of patients at 5, 7, and 10 minutes was 80.7%, 84.4%, and 88.1%, respectively, in the FS Grifols treatment group, and 28.1%, 35.1%, and 45.6% in the MC treatment group (P < .001). The median time to hemostasis was shorter in the FS Grifols group (4 minutes vs >/=10 minutes in the MC group; P < .001). The nature of AEs reported were those expected in the study patient profile. The percentage of patients experiencing treatment-emergent AEs were similar in both the FS Grifols (pooled n = 59 + 109) and MC groups (81.0% and 77.2%, respectively), most recurrent being procedural pain (34.5% and 36.8%, respectively) and pyrexia (11.3% and 10.5%, respectively). CONCLUSIONS: FS Grifols was superior in efficacy and similar in safety to MC as an adjunct local hemostatic agent in patients undergoing open vascular surgeries. CI - Copyright (c) 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. FAU - Nenezic, Dragoslav AU - Nenezic D AD - Institute for Cardiovascular Diseases "Dedinje", Clinic for Vascular Surgery, Belgrade, Serbia. Electronic address: neneza55@gmail.com. FAU - Ayguasanosa, Jaume AU - Ayguasanosa J AD - Grifols Bioscience Research Group, Grifols, Barcelona, Spain. FAU - Menyhei, Gabor AU - Menyhei G AD - Department of Vascular Surgery, Pecs University Clinical Center, Pecs, Hungary. FAU - Tamas, Holjencsik AU - Tamas H AD - Department of Vascular Surgery, Csolnoky Ferenc County Hospital, Veszprem, Hungary. FAU - Matyas, Lajos AU - Matyas L AD - Department of Vascular and Endovascular Surgery, Borsod Teaching County Hospital Miskolc, Borsod, Hungary. FAU - Muluk, Satish AU - Muluk S AD - Division of Vascular Surgery, Allegheny General Hospital, Pittsburgh, Pa. FAU - Courtney, Kecia AU - Courtney K AD - Grifols Bioscience Research Group, Grifols, Barcelona, Spain. FAU - Ibanez, Julia AU - Ibanez J AD - Grifols Bioscience Research Group, Grifols, Barcelona, Spain. FAU - Chen, Junliang AU - Chen J AD - Grifols Bioscience Research Group, Grifols, Barcelona, Spain. CN - investigators of the Fibrin Sealant Grifols in Vascular Surgery Clinical Investigation Study Group LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190326 PL - United States TA - J Vasc Surg JT - Journal of vascular surgery JID - 8407742 RN - 0 (Fibrin Tissue Adhesive) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Blood Loss, Surgical/*prevention & control/statistics & numerical data MH - Female MH - Fibrin Tissue Adhesive/*administration & dosage/adverse effects MH - Hemostasis, Surgical/*methods MH - Humans MH - Male MH - Middle Aged MH - Pressure MH - Prospective Studies MH - Single-Blind Method MH - Treatment Outcome MH - Vascular Surgical Procedures/*adverse effects MH - Young Adult OTO - NOTNLM OT - Fibrin sealant OT - Hemostasis OT - Plasma-derived OT - Vascular surgery FIR - Segura-Vasi, Alvaro IR - Segura-Vasi A FIR - Sokurenko, German IR - Sokurenko G FIR - Paramesh, Anil IR - Paramesh A FIR - Minkowitz, Harold IR - Minkowitz H FIR - Sonkin, Igor IR - Sonkin I FIR - Lal, Brajesh IR - Lal B FIR - Ihnat, Daniel IR - Ihnat D FIR - Brooke, Benjamin IR - Brooke B FIR - Popovic, Vladan IR - Popovic V FIR - Eslami, Mohammad IR - Eslami M FIR - Farber, Alik IR - Farber A FIR - Saha, Sibu IR - Saha S FIR - Greenstein, Stuart IR - Greenstein S FIR - Karpenko, Andrey IR - Karpenko A FIR - Katelnitskiy, Ivan IR - Katelnitskiy I FIR - Tran, Nam IR - Tran N FIR - Hoch, John IR - Hoch J FIR - Amin, Ali IR - Amin A FIR - White, Paul IR - White P FIR - Rajani, Ravi R IR - Rajani RR FIR - Griffin, Joseph IR - Griffin J FIR - Yurvati, Albert IR - Yurvati A FIR - Matsuura, John IR - Matsuura J FIR - Navarro-Puerto, Jordi IR - Navarro-Puerto J FIR - Barrera, Gladis IR - Barrera G FIR - Hames, Carrie IR - Hames C FIR - Lloyd, Valerie IR - Lloyd V FIR - Zhang, Yanmei IR - Zhang Y FIR - Lin, Jiang IR - Lin J FIR - Li, Henry IR - Li H FIR - Covington, Deborah IR - Covington D FIR - Henriquez, Waleska IR - Henriquez W FIR - Soucheiron, Carmen IR - Soucheiron C FIR - Beck, Susan IR - Beck S FIR - Casamiquela, Roma IR - Casamiquela R EDAT- 2019/03/31 06:00 MHDA- 2020/05/28 06:00 CRDT- 2019/03/31 06:00 PHST- 2018/08/03 00:00 [received] PHST- 2018/12/03 00:00 [accepted] PHST- 2019/03/31 06:00 [pubmed] PHST- 2020/05/28 06:00 [medline] PHST- 2019/03/31 06:00 [entrez] AID - S0741-5214(19)30214-9 [pii] AID - 10.1016/j.jvs.2018.12.051 [doi] PST - ppublish SO - J Vasc Surg. 2019 Nov;70(5):1642-1651. doi: 10.1016/j.jvs.2018.12.051. Epub 2019 Mar 26.