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.
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Funding
This work was entirely funded by Thrombotargets Europe S.L.
Conflict of interest
RL, IM, BA, PS, ER, JRR, SR, and JM are employed by this company. The other authors declare no conflict of interest.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent
Informed consent was obtained from all individual participants included in the study.
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López-López, J., Jané-Salas, E., Santamaría, A. et al. TETIS study: evaluation of new topical hemostatic agent TT-173 in tooth extraction. Clin Oral Invest 20, 1055–1063 (2016). https://doi.org/10.1007/s00784-015-1586-1
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DOI: https://doi.org/10.1007/s00784-015-1586-1