José López-López1, Enric Jané-Salas2, Amparo Santamaría3, Beatriz González-Navarro2, Carlos Arranz-Obispo2, Ramón López4, Ignasi Miquel4, Belén Arias4, Pilar Sánchez4, Esther Rincón4, Juan R Rodríguez4, Santiago Rojas4, Jesus Murat4. 1. Department of Odontostomatology, School of Dentistry-Hospital Odontológico Universidad de Barcelona, Barcelona University, C/Feixa Llarga s/n, 08907, Hospitalet de Llobregat, Barcelona, Spain. 18575jll@gmail.com. 2. Department of Odontostomatology, School of Dentistry-Hospital Odontológico Universidad de Barcelona, Barcelona University, C/Feixa Llarga s/n, 08907, Hospitalet de Llobregat, Barcelona, Spain. 3. Hemostasia and Thrombosis Unit, Department of Hematology, Hospital Universitari Vall d'Hebrón, Barcelona, Spain. 4. S.L. Parque Mediterráneo de la Tecnología, Thombotargets Europe, Castelldefels, Spain.
Abstract
OBJECTIVES:TT-173 is a new hemostatic agent consisting of yeast-derived microvesicles containing a modified version of recombinant human tissue factor. In the present work, the procoagulant activity of TT-173 has been evaluated for the first time in humans. METHODS: This is a phase I, randomized, placebo-controlled study to evaluate the efficacy, safety, systemic absorption, and immunogenicity of TT-173 in healthy volunteers undergoing tooth extraction. Subjects received TT-173 or placebo into the alveolar cavity, just after tooth extraction. Time to clot formation, bleeding time, and adverse events were recorded. RESULTS: Treatment with TT-173 reduced the bleeding time and the time to clot formation. No adverse events related with product administration were reported. In the same way, neither systemic absorption nor immunogenic reaction against the product was detected. Our findings pave the way to evaluate the usefulness of this new topical hemostatic agent in more complex oral surgeries and in those patients affected with coagulation disorders that may compromise the realization of dental procedures. CONCLUSION: The new hemostatic agent TT-173 has proven efficacious and safe in healthy subjects undergoing tooth extraction supporting its further evaluation in more complex surgeries. CLINICAL RELEVANCE: The development of this new topical hemostatic agent could contribute to bleeding control in oral and maxillofacial surgery.
RCT Entities:
OBJECTIVES:TT-173 is a new hemostatic agent consisting of yeast-derived microvesicles containing a modified version of recombinant humantissue factor. In the present work, the procoagulant activity of TT-173 has been evaluated for the first time in humans. METHODS: This is a phase I, randomized, placebo-controlled study to evaluate the efficacy, safety, systemic absorption, and immunogenicity of TT-173 in healthy volunteers undergoing tooth extraction. Subjects received TT-173 or placebo into the alveolar cavity, just after tooth extraction. Time to clot formation, bleeding time, and adverse events were recorded. RESULTS: Treatment with TT-173 reduced the bleeding time and the time to clot formation. No adverse events related with product administration were reported. In the same way, neither systemic absorption nor immunogenic reaction against the product was detected. Our findings pave the way to evaluate the usefulness of this new topical hemostatic agent in more complex oral surgeries and in those patients affected with coagulation disorders that may compromise the realization of dental procedures. CONCLUSION: The new hemostatic agent TT-173 has proven efficacious and safe in healthy subjects undergoing tooth extraction supporting its further evaluation in more complex surgeries. CLINICAL RELEVANCE: The development of this new topical hemostatic agent could contribute to bleeding control in oral and maxillofacial surgery.
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