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35. 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

Author

Bjelović Miloš, Ayguasanosa Jaume, Kim Robin D, Stojanović Miroslav, Vereczkei Andras, Nikolić Srdjan, Winslow Emily, Emre Sukru, Xiao Gary, Navarro-Puerto Jordi, Courtney Kecia, Barrera Gladis, and On behalf of the investigators of the Fibrin Sealant Grifols in Hepatic Resection Clinical Investigation Study Group

Subjects
Fibrin sealant, Liver resection, Local hemostasis, Oxidized cellulose, Parenchymous surgery
Abstract

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 (T4) 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 T2, T3, T5, T7, and T10. Results The rate of hemostasis by T4 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 T2, T5, and T7 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.

Published
2018

42. Prospective, double‐blind, randomized clinical trial comparing an ERASpathway with ketorolac and pregabalin versus standard of care plus placebo during live donor nephrectomy for kidney transplant

Author

Campsen, Jeffrey, Call, Tyler, Allen, Chelsea McCarty, Presson, Angela P., Martinez, Eryberto, Rofaiel, George, and Kim, Robin D.

Abstract

Opioid exposure is a concern after live donation for kidney transplant. We theorized that an enhanced recovery after surgery pathway (ERAS) using pregabalin preoperatively to desensitize nerves followed by the nonsteroidal anti‐inflammatory drug ketorolac, during and after surgery, can control pain, thus requiring less perioperative narcotics. The aim of this study was to determine if the use of a nonopioid analgesic ERASprotocol for donor nephrectomies could decrease the use of narcotics without an increase in complications compared with standard of care (SOC). This is a single‐center, prospective, double‐blind, randomized clinical trial involving a total of 62 patients undergoing nephrectomy for live donor kidney transplant. Length of hospital stay (LOS) was significantly reduced by 10% in the ERASgroup versus the SOC‐plus‐placebo group. Morphine dose equivalents were significantly reduced by 40% in the study group versus the SOC‐plus‐placebo group. The use of this nonopioid analgesic ERASpathway for donor nephrectomies decreased the use of narcotics without an increase in complications compared with SOC. There was significantly reduced LOSand less narcotic use in the study group versus the SOC‐plus‐placebo group. (ClinicalTrials.gov registration number: NCT03669081). This double‐blind, randomized study evaluates an enhanced postsurgery recovery pathway consisting of ketorolac and pregabalin, with the aim of lowering postoperative opioid use in live kidney donors.

Published
2019
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