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.
|
Authors | Hiroshi Masuhara, Takeshiro Fujii, Yoshinori Watanabe, Nobuya Koyama, Keiichi Tokuhiro |
Journal | Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia
(Ann Thorac Cardiovasc Surg)
Vol. 18
Issue 5
Pg. 444-51
( 2012)
ISSN: 2186-1005 [Electronic] Japan |
PMID | 22986759
(Publication Type: Journal Article)
|
Chemical References |
- Gels
- Hemostatics
- Peptides
- acetyl-(arginyl-alanyl-aspartyl-alanyl)4-amide
|
Topics |
- Aged
- Aged, 80 and over
- Animals
- Aortic Aneurysm, Abdominal
(surgery)
- Blood Vessel Prosthesis Implantation
- Chemistry Techniques, Synthetic
- Coronary Artery Bypass
- Disease Models, Animal
- Female
- Gels
- Hemostatics
(therapeutic use)
- Humans
- Male
- Middle Aged
- Peptides
(therapeutic use)
- Peripheral Arterial Disease
(surgery)
- Rabbits
- Reoperation
- Treatment Outcome
- Vascular Surgical Procedures
|