EHTIC study: evaluation of a new hemostatic agent based on tissue factor in skin grafting procedures

Thombotargets Europe, S.L., Parque Mediterraneo de la Tecnologia, Castelldefels, Spain; Unit of Human Anatomy and Embryology, Department of Morphological Sciences, Faculty of Medicine, Autonomous University of Barcelona, Cerdanyola del Valles, Spain; Department of Plastic Surgery, La Fe University and Polytechnic Hospital, Valencia, Spain; Department of Plastic Surgery, La Paz University Hospital, Madrid, Spain; Department of Plastic Surgery, University Hospital Complex of A Coruna, A Coruna, Spain; Department of Plastic Surgery, University Hospital of Getafe, Getafe, Spain.

Burns : Journal of the International Society for Burn Injuries. 2017;43((4):):780-788
BACKGROUND Excessive bleeding is a major concern in scar debridement and grafting procedures. TT-173 is a new topical hemostatic agent based on recombinant human tissue factor that has shown promising results in patients who underwent tooth extraction. EHTIC study sought to evaluate the efficacy and safety of TT-173 to reduce the bleeding in donor sites of skin grafting procedures. METHODS EHTIC study was a phase II, randomized, parallel, double blind, placebo controlled trial. Patients received TT-173 (n=38) or placebo (n=33) sprayed over donor site after graft harvest. Time to hemostasis and incidence of adverse events were recorded. Systemic absorption of the product and its immunogenicity were also measured during the follow up of the subjects. RESULTS Treatment with TT-173 significantly reduced the bleeding time from 7 to 3min (Log-Rank p<0.0001). Moreover, bleeding stopped within the 10min of evaluation period in all the patients that received TT-173. In contrast, 24.24% of patients from placebo group required additional measures to arrest hemorrhage (Fisher p=0.0013). Product related adverse events, systemic absorption into blood stream, interferences with the healing of the donor site or immunogenic reaction against TT-173 were not observed. CONCLUSION The new hemostatic agent TT-173 has proven efficacious and safe to reduce the bleeding from donor site. This study paves the way for further investigation of the product as topical hemostatic treatment in plastic surgery and other surgical indications.
Study details
Language : English
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine