1. Novel infectious agent-free hemostatic material (TDM-621) in cardiovascular surgery.
- Author
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Masuhara H, Fujii T, Watanabe Y, Koyama N, and Tokuhiro K
- Subjects
- Aged, Aged, 80 and over, Animals, Disease Models, Animal, Female, Gels, Humans, Male, Middle Aged, Rabbits, Reoperation, Treatment Outcome, Vascular Surgical Procedures, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation, Chemistry Techniques, Synthetic, Coronary Artery Bypass, Hemostatics therapeutic use, Peptides therapeutic use, Peripheral Arterial Disease surgery
- Abstract
Subjects: Currently, hemostatic materials made from human blood components and animal-derived collagen is used for controlling operative hemorrhage in the cardiovascular surgery field. In this study, we focused on an entirely synthetic self-assembling peptide (development code: TDM-621) that gels when in contact with blood or other bodily fluids and stops bleeding upon contact with a wound site. We investigated its usefulness as a hemostatic material in animal and clinical studies., Methods: Before we began the clinical study, we demonstrated the hemostasis efficacy and safety of TDM-621 in animal experimental models. Twenty-five patients (22 men, 3 women) were enrolled in the clinical study, and the following procedures were performed: 1) coronary artery bypass graft (CABG) (n = 9), 2) abdominal aortic graft replacement (n = 4), and 3) peripheral artery bypass (n = 12). The TDM-621 material was applied to a total of 33 vascular anastomotic graft sites (some patients received material at more than one site). Both hemostatic efficacy and safety were examined., Results: A total of 33 anastomotic graft sites in 25 patients were evaluated, and the averaged primary and secondary efficacy rate was 94.5%. No postoperative bleeding or adverse events (including serious adverse events) with a causal relationship to treatment were observed., Conclusion: This study indicated that TDM-621 is a more effective and reliable hemostat than commonly-used general hemostatic agents and, therefore, will be very useful in several cardiovascular surgery applications.
- Published
- 2012
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