Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the packing. Additionally, there is a great deal of pain during the insertion and removal of this packing. This study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. Thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.

开始日期2008-12-01

申办/合作机构

University of Kansas

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100 项与 Thrombin, Topical (Bovine)(GenTrac) 相关的临床结果

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100 项与 Thrombin, Topical (Bovine)(GenTrac) 相关的转化医学

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100 项与 Thrombin, Topical (Bovine)(GenTrac) 相关的专利（医药）

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项与 Thrombin, Topical (Bovine)(GenTrac) 相关的文献（医药）

2024-03-01·The Laryngoscope

Effects of Short‐term Electronic(e)‐Cigarette Aerosol Exposure in the Mouse Larynx

Article

作者: Soo, Joanne ; Hung, Barbara ; Maria, Chloe Santa ; Easwaran, Meena ; Erickson‐DiRenzo, Elizabeth ; Kimura, Akari ; Martinez, Joshua D. ; Yu, Xuan ; Gross, Eric R.

ObjectivesThe effects of electronic cigarettes (e‐cigarettes) on the larynx are relatively unknown. This study examined the short‐term effects of e‐cigarette inhalation on cellular and inflammatory responses within the mouse laryngeal glottic and subglottic regions after exposure to pod‐based devices (JUUL).MethodsMale C57BL6/J mice (8–9 weeks) were assigned to control (n = 9), JUUL flavors Mint (JMi; n = 10) or Mango (JMa; n = 10). JUUL mice were exposed to 2 h/day for 1, 5, and 10 days using the inExpose inhalation system. Control mice were in room air. Vocal fold (VF) epithelial thickness, cell proliferation, subglandular area and composition, inflammatory cell infiltration, and surface topography were evaluated in the harvested larynges. Mouse body weight and urinary nicotine biomarkers were also measured. Chemical analysis of JUUL aerosols was conducted using selective ion flow tube mass spectrometry.ResultsJUUL‐exposed mice had reduced body weight after day 5. Urinary nicotine biomarker levels indicated successful JUUL exposure and metabolism. Quantitative analysis of JUUL aerosol indicated that chemical constituents differ between JMi and JMa flavors. VF epithelial thickness, cellular proliferation, glandular area, and surface topography remained unchanged after JUUL exposures. Acidic mucus content increased after 1 day of JMi exposure. VF macrophage and T‐cell levels slightly increased after 10 days of JMi exposures.ConclusionsShort‐term e‐cigarette exposures cause minimal flavor‐ and region‐specific cellular and inflammatory changes in the mouse larynx. This work provides a foundation for long‐term studies to determine if these responses are altered with multiple e‐cigarette components and concentrations.Level of EvidenceN/A Laryngoscope, 134:1316–1326, 2024

2019-11-01·Journal of the American College of Surgeons2区 · 医学

Prospective, Randomized, Phase II, Non-Inferiority Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgery

2区 · 医学

Article

作者: Levester Kirksey ; Charles Cousar ; Daniel Labow ; Gladis Barrera ; Christopher D. Anderson ; Shankar Lakshman ; Waleska T. Henriquez ; Alan Villavicencio ; Patricia Sheiner ; Junliang Cheng ; Kecia Courtney ; Harold Minkowitz ; Harry Lockstadt ; Thomas Fishbein ; Sonia Singla ; Jordi Navarro-Puerto ; Robin Kim ; Jaume Ayguasanosa

BACKGROUNDThrombin-based formulations have been used for topical hemostasis in surgery for decades. However, the number of randomized clinical trials comparing bovine vs human thrombin is limited.STUDY DESIGNA randomized, double-blind, non-inferiority phase II study evaluated the hemostatic efficacy and safety of plasma-derived topical thrombin (human) Grifols (TTH-Grifols; Instituto Grifols SA) vs bovine THROMBIN JMI (BT-JMI; GenTrac Inc) (2:1 ratio) in vascular, hepatic, soft tissue, and spinal operations. The primary efficacy end point was the percentage of patients achieving hemostasis at target bleeding sites with mild to moderate bleeding (response) within 5 minutes (T₅) of treatment application. Non-inferiority was met if the lower limit of the 95% CI of the response ratio of TTH-Grifols relative to BT-JMI by T₅ exceeded 0.8. Secondary efficacy variables were the cumulative response by 3 and 4 minutes (T₃ and T₄), and the number of treatment failures. Safety parameters were assessed.RESULTSRandomized patients in TTH-Grifols and BT-JMI groups were n = 137 and n = 68, respectively. In modified intention-to-treat population, rates of hemostasis by T₅ were 78.3% (94 of 120) in TTH-Grifols and 80.3% (49 of 61) in BT-JMI (response ratio: 0.973; 95% CI 0.833 to 1.135). Rates of hemostasis in vascular, hepatic, soft tissue, and spinal operations ranged from 75.0% to 82.5% for TTH-Grifols and from 54.5% to 91.7% for BT-JMI. No significant differences in adverse events were observed between treatment groups. Antibodies to bovine factor V antigen were detected in 2 patients exposed to BT-JMI and in none exposed to TTH-Grifols.CONCLUSIONSThe TTH-Grifols was safe and well tolerated as a local hemostatic agent and was non-inferior to BT-JMI. No antibodies to thrombin developed in TTH-Grifols-treated patients.

2016-10-01·Journal of Thrombosis and Thrombolysis4区 · 医学

Improved bleeding scores using Gelfoam® Powder with incremental concentrations of bovine thrombin in a swine liver lesion model

4区 · 医学

Article

作者: Silva, Elif ; Potter, David ; Morse, Dennis C ; Bieber, Trevor ; Young, Kelli ; Bass, Eric J ; Bartrom, Jolee

Topical hemostatic agents are used intra-operatively to prevent uncontrolled bleeding. Gelfoam(®) Powder contains a hemostatic agent prepared from purified pork skin gelatin, the efficacy of which is increased when combined with thrombin. However, the effect of increasing concentrations of thrombin on resultant hemostasis is not known. This study sought to evaluate the ability of various concentrations of thrombin in combination with Gelfoam Powder to control bleeding using a swine liver lesion model. Ten pigs underwent a midline laparotomy. Circular lesions were created in the left medial, right medial, and left lateral lobes; six lesions per lobe. Gelfoam Powder was hydrated with Thrombin-JMI(®) diluted to 250, 375, and 770 IU/mL. Each concentration was applied to two lesion sites per lobe. Bleeding scores were measured at 3, 6, 9, and 12 min using a 6-point system; comparison of bleeding scores was performed using ANOVA with the post hoc Tukey test. The bleeding scores with thrombin concentrations at 770 IU/mL were significantly lower than at 250 and 375 IU/mL at all four time points. The percentage of biopsies with a clinically acceptable bleeding score rose from 37.9, 46.6, and 71.2 % at 3 min to 55.2, 69.0, and 88.1 % at 12 min in the 250, 375, and 770 IU/mL thrombin groups, respectively. The study showed that the hemostatic response to thrombin was dose-related: using higher concentrations of thrombin with Gelfoam Powder yielded improved hemostasis, as determined by lower bleeding scores.

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