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

investigators of the Fibrin Sealant Grifols in Vascular Surgery Clinical Investigation Study Group

Research output: Contribution to journalArticleResearchpeer-review

Abstract

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.

Original languageEnglish
JournalJournal of Vascular Surgery
DOIs
StatePublished - 1 Jan 2019

Fingerprint

Fibrin Tissue Adhesive
Hemostasis
Blood Vessels
Safety
Hemostatics
Vascular Surgical Procedures
Phase III Clinical Trials
Vital Signs
Proxy
Therapeutics
Sutures
Fever
Biomarkers
Hemorrhage
Pain

Keywords

  • Fibrin sealant
  • Hemostasis
  • Plasma-derived
  • Vascular surgery

Cite this

@article{949bbf2f9bf2481eb4207409fa4eaba9,
title = "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",
abstract = "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.",
keywords = "Fibrin sealant, Hemostasis, Plasma-derived, Vascular surgery",
author = "{investigators of the Fibrin Sealant Grifols in Vascular Surgery Clinical Investigation Study Group} and Dragoslav Nenezić and Jaume Ayguasanosa and G{\'a}bor Menyhei and Holjencsik Tam{\'a}s and Lajos M{\'a}ty{\'a}s and Satish Muluk and Kecia Courtney and Julia Ib{\'a}{\~n}ez and Junliang Chen and Alvaro Segura-Vasi and German Sokurenko and Anil Paramesh and Harold Minkowitz and Igor Sonkin and Brajesh Lal and Daniel Ihnat and Benjamin Brooke and Vladan Popović and Mohammad Eslami and Alik Farber and Sibu Saha and Stuart Greenstein and Andrey Karpenko and Ivan Katelnitskiy and Nam Tran and John Hoch and Ali Amin and Paul White and Rajani, {Ravi R.} and Joseph Griffin and Albert Yurvati and Albert Yurvati and Jordi Navarro-Puerto and Gladis Barrera and Carrie Hames and Valerie Lloyd and Yanmei Zhang and Jiang Lin and Henry Li and Deborah Covington and Waleska Henriquez and Carmen Soucheiron and Susan Beck and Rom{\`a} Casamiquela",
year = "2019",
month = "1",
day = "1",
doi = "10.1016/j.jvs.2018.12.051",
language = "English",
journal = "Journal of Vascular Surgery",
issn = "0741-5214",
publisher = "Mosby Inc.",

}

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. / investigators of the Fibrin Sealant Grifols in Vascular Surgery Clinical Investigation Study Group.

In: Journal of Vascular Surgery, 01.01.2019.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - 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

AU - investigators of the Fibrin Sealant Grifols in Vascular Surgery Clinical Investigation Study Group

AU - Nenezić, Dragoslav

AU - Ayguasanosa, Jaume

AU - Menyhei, Gábor

AU - Tamás, Holjencsik

AU - Mátyás, Lajos

AU - Muluk, Satish

AU - Courtney, Kecia

AU - Ibáñez, Julia

AU - Chen, Junliang

AU - Segura-Vasi, Alvaro

AU - Sokurenko, German

AU - Paramesh, Anil

AU - Minkowitz, Harold

AU - Sonkin, Igor

AU - Lal, Brajesh

AU - Ihnat, Daniel

AU - Brooke, Benjamin

AU - Popović, Vladan

AU - Eslami, Mohammad

AU - Farber, Alik

AU - Saha, Sibu

AU - Greenstein, Stuart

AU - Karpenko, Andrey

AU - Katelnitskiy, Ivan

AU - Tran, Nam

AU - Hoch, John

AU - Amin, Ali

AU - White, Paul

AU - Rajani, Ravi R.

AU - Griffin, Joseph

AU - Yurvati, Albert

AU - Yurvati, Albert

AU - Navarro-Puerto, Jordi

AU - Barrera, Gladis

AU - Hames, Carrie

AU - Lloyd, Valerie

AU - Zhang, Yanmei

AU - Lin, Jiang

AU - Li, Henry

AU - Covington, Deborah

AU - Henriquez, Waleska

AU - Soucheiron, Carmen

AU - Beck, Susan

AU - Casamiquela, Romà

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

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.

KW - Fibrin sealant

KW - Hemostasis

KW - Plasma-derived

KW - Vascular surgery

UR - http://www.scopus.com/inward/record.url?scp=85063352005&partnerID=8YFLogxK

U2 - 10.1016/j.jvs.2018.12.051

DO - 10.1016/j.jvs.2018.12.051

M3 - Article

JO - Journal of Vascular Surgery

JF - Journal of Vascular Surgery

SN - 0741-5214

ER -