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Ann Thorac Cardiovasc Surg. 2012;18(5):444-51. Epub 2012 Sep 14.

Novel infectious agent-free hemostatic material (TDM-621) in cardiovascular surgery.

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1
Division of Cardiovascular Center, Department of Surgery, Toho University, Sakura Medical Center, Chiba, Japan. masuhara@med.toho-u.ac.jp

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.

PMID:
22986759
[Indexed for MEDLINE]
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