title: Novel infectious agent-free hemostatic material (TDM-621) in cardiovascular surgery.
abstract: METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Cardiovascular Center, Department of Surgery, Toho University, Sakura Medical Center, Chiba, Japan. masuhara@med.toho-u.ac.jp
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Masuhara
authors.forename: Takeshiro
authors.initials: T
authors.lastname: Fujii
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Watanabe
authors.forename: Nobuya
authors.initials: N
authors.lastname: Koyama
authors.forename: Keiichi
authors.initials: K
authors.lastname: Tokuhiro
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D017544:Aortic Aneurysm, Abdominal / Q000601:surgery*; D019917:Blood Vessel Prosthesis Implantation; D060326:Chemistry Techniques, Synthetic; D001026:Coronary Artery Bypass; D004195:Disease Models, Animal; D005260:Female; D005782:Gels; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000627:therapeutic use*; D058729:Peripheral Arterial Disease / Q000601:surgery*; D011817:Rabbits; D012086:Reoperation; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures
chemical_list: D005782:Gels; D006490:Hemostatics; D010455:Peptides; C581206:acetyl-(arginyl-alanyl-aspartyl-alanyl)4-amide