Evaluating the Efficacy and Safety of Hemofence (Thorombin Cross-Linked Sodium Hyaluronate Gel Matrix) in Hemostasis for Intractable Exudative Bleeding in Spinal Surgery: A Multicenter, Randomized, Phase III Clinical Trial

Article

Author: Lee, Jang-Bo ; Hur, Junseok W ; An, Sungjae ; Kim, Joohyun ; Kwon, Woo-Keun ; Choi, Il

Objective: To demonstrate the noninferiority of the novel hemostatic agent, Hemofence (BMI Korea Co., Ltd., thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety.Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallel-group, phase 3 study. Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis. Subsequent visits were conducted for safety assessments. For noninferiority test, a 97.5% one-sided confidence interval (CI) was used; the test group was deemed noninferior if the lower limit exceeded -10%.Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy. The 95% CI (-4.90% to 7.44%) confirmed the test drug’s noninferiority. Time to hemostasis showed no significant difference between groups. All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.000, p=0.243, and p=0.966, respectively).Conclusion: A novel hemostatic agent, Hemofence, demonstrated an efficacy and safety profile comparable to that of Floseal.

01 Sep 2024·Asian Journal of Neurosurgery

Usefulness and Safety of Gelatin–Thrombin Matrix Sealants in Minimally Invasive Microscopic Discectomy

Article

Author: Nakahara, Yukiko ; Ozaki, Tomonori ; Masuoka, Jun ; Abe, Tatsuya ; Naruo, Seiichiro ; Sakamoto, Yushi ; Tahata, Shogo ; Yoshioka, Fumitaka ; Ogata, Atushi ; Fujimoto, Toru

Abstract Objective This study aimed to evaluate the usefulness and safety of gelatin–thrombin matrix sealants (GTMSs) in minimally invasive microscopic discectomy, a surgical procedure commonly used to treat lumbar disc herniation. Materials and Methods Out of 484 patients who underwent minimally invasive microscopic discectomy between April 2018 and December 2022, 35 patients with a history of surgery at the same level were excluded, resulting in a total of 449 patients included in the study. Among them, 316 patients were treated using GTMS, whereas 133 were treated using collagen-based absorbable local hemostatic agents. Patient characteristics, surgical duration, intraoperative blood loss, postoperative drainage volume, intraoperative dural injury, and incidence of postoperative epidural hematoma were analyzed and compared between the two groups. Results No significant differences in patient demographics were observed between the two groups, except for activated partial thromboplastin time and prothrombin time. Although there were no significant differences in the mean surgical time and intraoperative blood loss between the two groups, they tended to be shorter and less in the GTMS group (56.3 ± 20.2 vs. 58.2 ± 20.4 minutes [p = 0.36] and 10.0 ± 15.4 vs. 11.8 ± 8.3 g [p = 0.20]). The volume of postoperative drainage was significantly lower in the GTMS group than that in the comparison group (35.3 ± 21.8 vs. 49.5 ± 34.1 g [p < 0.01]). There was a trend indicating a difference in the number of intraoperative dural injuries and the need for reoperation due to postoperative epidural hematoma (2 vs. 3 ± 20.4 minutes [p = 0.21] and 1 vs. 2 [p = 0.16]). Conclusion The use of a GTMS in minimally invasive microscopic discectomy appears to be beneficial in reducing postoperative drainage volume. It has also been shown that it may improve clinical outcomes such as intraoperative dural injury and postoperative epidural hematoma. Furthermore, further consideration of the medical economic impact is required.

01 Aug 2024·Zhongguo shi yan xue ye xue za zhi

[Study on the Experimental Methodology of Plasma Clot Retraction].

Article

Author: Luo, Yang-Gan ; Huang, Man-Jing ; Lu, Zi-Han ; Liao, Han-Jing ; Zhu, Zhi-Xiang ; Hao, Dou-Dou

OBJECTIVETo explore the key factors affecting plasma clot retraction and optimize the experimental method of plasma clot retraction, in order to study the regulation of platelet function and evaluate the modulatory effects of drugs on plasma clot retraction.METHODSThe effects of different concentrations of thrombin, Ca2 ⁺ and platelets on plasma clot retraction were studied, and the detection system of plasma clot retraction was optimized. The availability of the detection system was then validated by analyzing the regulatory effects of multiple signaling pathway inhibitors on plasma clot retraction.RESULTSThrough the optimization study of multiple factors, platelet rich plasma (PRP) containing 0.5 mmol/L Ca2 ⁺ and 40×10⁹/L platelets was treated with 0.2 U/ml thrombin to perform plasma clot retraction analysis. After treatment with thrombin for 15 min, plasma clot retracted significantly. After treatment with thrombin for 30 min, the percentage of plasma clot retraction was more than 50%. The regulatory effects of multiple signaling pathway inhibitors on plasma clot retraction were studied in this detection system. PKC inhibitor Go 6983 exhibited a significant inhibitory effect on plasma clot retraction, while PI3K inhibitor Ly294002 and p38 MAPK inhibitor SB203580 slightly suppressed plasma clot retraction.CONCLUSIONPRP containing 0.5 mmol/L Ca2 ⁺ and 40×10⁹/L platelets can be induced with 0.2 U/ml thrombin to conduct plasma clot retraction analysis, which can be used to study the regulation of platelet function and evaluate the modulatory effects of drugs on plasma clot retraction.

100 Deals associated with Thrombin (BMI KOREA)

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Indication	Country/Location	Organization	Date
Hemorrhage	KR	BMI Korea Co., Ltd.	16 Feb 2024

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10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemostatic Disorders	NDA/BLA	-	BMI Korea Co., Ltd.	-

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