title: TETIS study: evaluation of new topical hemostatic agent TT-173 in tooth extraction.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  The development of this new topical hemostatic agent could contribute to bleeding control in oral and maxillofacial surgery.
authors.affiliation: 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.
authors.forename: José
authors.initials: J
authors.lastname: López-López
authors.affiliation: Department of Odontostomatology, School of Dentistry-Hospital Odontológico Universidad de Barcelona, Barcelona University, C/Feixa Llarga s/n, 08907, Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Enric
authors.initials: E
authors.lastname: Jané-Salas
authors.affiliation: Hemostasia and Thrombosis Unit, Department of Hematology, Hospital Universitari Vall d'Hebrón, Barcelona, Spain.
authors.forename: Amparo
authors.initials: A
authors.lastname: Santamaría
authors.affiliation: Department of Odontostomatology, School of Dentistry-Hospital Odontológico Universidad de Barcelona, Barcelona University, C/Feixa Llarga s/n, 08907, Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: González-Navarro
authors.affiliation: Department of Odontostomatology, School of Dentistry-Hospital Odontológico Universidad de Barcelona, Barcelona University, C/Feixa Llarga s/n, 08907, Hospitalet de Llobregat, Barcelona, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Arranz-Obispo
authors.affiliation: S.L. Parque Mediterráneo de la Tecnología, Thombotargets Europe, Castelldefels, Spain.
authors.forename: Ramón
authors.initials: R
authors.lastname: López
authors.affiliation: S.L. Parque Mediterráneo de la Tecnología, Thombotargets Europe, Castelldefels, Spain.
authors.forename: Ignasi
authors.initials: I
authors.lastname: Miquel
authors.affiliation: S.L. Parque Mediterráneo de la Tecnología, Thombotargets Europe, Castelldefels, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Arias
authors.affiliation: S.L. Parque Mediterráneo de la Tecnología, Thombotargets Europe, Castelldefels, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Sánchez
authors.affiliation: S.L. Parque Mediterráneo de la Tecnología, Thombotargets Europe, Castelldefels, Spain.
authors.forename: Esther
authors.initials: E
authors.lastname: Rincón
authors.affiliation: S.L. Parque Mediterráneo de la Tecnología, Thombotargets Europe, Castelldefels, Spain.
authors.forename: Juan R
authors.initials: JR
authors.lastname: Rodríguez
authors.affiliation: S.L. Parque Mediterráneo de la Tecnología, Thombotargets Europe, Castelldefels, Spain.
authors.forename: Santiago
authors.initials: S
authors.lastname: Rojas
authors.affiliation: S.L. Parque Mediterráneo de la Tecnología, Thombotargets Europe, Castelldefels, Spain.
authors.forename: Jesus
authors.initials: J
authors.lastname: Murat
mesh_terms: D000287:Administration, Topical; D000328:Adult; D005260:Female; D006490:Hemostatics / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D006472:Oral Hemorrhage / Q000517:prevention & control*; D011446:Prospective Studies; D016037:Single-Blind Method; D013925:Thromboplastin / Q000008:administration & dosage / Q000494:pharmacology*; D014081:Tooth Extraction; D016896:Treatment Outcome
chemical_list: D006490:Hemostatics; D013925:Thromboplastin
keywords: Surgical bleeding; TT-173; Thrombin; Tissue factor; Tooth extraction; Topical hemostatic