| 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 |
Sungjae An1 
, Woo-Keun Kwon2
, Il Choi3
, Jang-Bo Lee1,4
, Joohyun Kim1
, Junseok W. Hur1
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1Department of Neurosurgery, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea
2Department of Neurosurgery, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
3Department of Neurosurgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea
4Department of Neurosurgery, University of Iowa Hospitals & Clinics, Iowa City, IA, USA |
Corresponding Author:
Junseok W. Hur
Tel: 02-920-5729 Fax: 02-929-0629 Email: hurjune@gmail.com
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Received: January 4, 2024 Revised: February 4, 2024 Accepted: February 22, 2024 |
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| Abstract |
Objective
To demonstrate the non-inferiority of the novel hemostatic agent, Hemofence® (BMI Korea Co. Ltd., Jeju Korea, 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 non-inferiority test, a 97.5% one-sided confidence interval was used; the test group was deemed non-inferior 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% confidence interval (-4.90%, 7.44%) confirmed the test drug's non-inferiority. 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=1.0000, p=0.2427, and p=0.9663, respectively).
Conclusion
A novel hemostatic agent, Hemofence®, demonstrated an efficacy and safety profile comparable to that of Floseal. |
| Keywords:
Hemostasis; Hemofence; Floseal; Hyaluronic acid; Thrombin; Spine |
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