Asset Details
Do you wish to reserve the book?
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
Hey, we have placed the reservation for you!
By the way, why not check out events that you can attend while you pick your title.
Oops! Something went wrong.
Looks like we were not able to place the reservation. Kindly try again later.
Are you sure you want to remove the book from the shelf?
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
Do you wish to request the book?
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
Please be aware that the book you have requested cannot be checked out. If you would like to checkout this book, you can reserve another copy
We have requested the book for you!
Your request is successful and it will be processed during the Library working hours. Please check the status of your request in My Requests.
Oops! Something went wrong.
Looks like we were not able to place your request. Kindly try again later.
Journal Article
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
2018
Overview
Background
Local hemostatic agents have a role in limiting bleeding complications associated with liver resection.
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
4
) 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
2
,
T
3
,
T
5
,
T
7
, and
T
10
.
Results
The rate of hemostasis by T
4
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
2
,
T
5
, and
T
7
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%).
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.
Publisher
Springer US,Springer Nature B.V
Subject
/ Aged
/ Blood Loss, Surgical - prevention & control
/ Cellulose, Oxidized - adverse effects
/ Cellulose, Oxidized - therapeutic use
/ Female
/ Fibrin Tissue Adhesive - adverse effects
/ Fibrin Tissue Adhesive - therapeutic use
/ Hemostasis, Surgical - methods
/ Hemostatics - adverse effects
/ Hemostatics - therapeutic use
/ Hepatectomy - adverse effects
/ Humans
/ Male
/ Medicine
/ Surgery
