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A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections.
- Source :
-
Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract [J Gastrointest Surg] 2018 Nov; Vol. 22 (11), pp. 1939-1949. Date of Electronic Publication: 2018 Jul 02. - Publication Year :
- 2018
-
Abstract
- Background: Local hemostatic agents have a role in limiting bleeding complications associated with liver resection.<br />Methods: In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (T <subscript>4</subscript> ) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points T <subscript>2</subscript> , T <subscript>3</subscript> , T <subscript>5</subscript> , T <subscript>7</subscript> , and T <subscript>10</subscript> .<br />Results: The rate of hemostasis by T <subscript>4</subscript> was 92.8% in the FS Grifols group (n = 163) and 80.5% in the Surgicel® group (n = 162) (p = 0.01). The mean TTH was significantly shorter (p < 0.001) in the FS Grifols group (2.8 ± 0.14 vs. 3.8 ± 0.24 min). The rate of hemostasis by T <subscript>2</subscript> , T <subscript>5</subscript> , and T <subscript>7</subscript> was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%).<br />Conclusions: FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.
- Subjects :
- Adult
Aged
Cellulose, Oxidized adverse effects
Cellulose, Oxidized therapeutic use
Female
Fibrin Tissue Adhesive adverse effects
Hemostatics adverse effects
Hepatectomy adverse effects
Humans
Hypotension etiology
Male
Middle Aged
Nausea etiology
Pain, Procedural etiology
Prospective Studies
Time Factors
Blood Loss, Surgical prevention & control
Fibrin Tissue Adhesive therapeutic use
Hemostasis, Surgical methods
Hemostatics therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1873-4626
- Volume :
- 22
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract
- Publication Type :
- Academic Journal
- Accession number :
- 29967969
- Full Text :
- https://doi.org/10.1007/s11605-018-3852-4