Papaefthymiou, ApostolisAslam, NasarHussein, MohamedAlzoubaidi, DuraydGross, SethDe La Serna, AlvaroVarbobitis, IoannisHengehold, TriciaFraile López, MiguelOrtiz Fernández-Sordo, JacoboRey, JohannesHayee, BuDespott, EdwardMurino, AlbertoMoreea, SullemanBoger, PhilDunn, JasonMainie, InderMullady, DanielEarly, DaynaLatorre, MelissaRagunath, KrishAnderson, JohnBhandari, PradeepGoetz, MartinKiesslich, RalfCoron, EmmanuelRodríguez De Santiago, EnriqueGonda, TamasO'Donnell, MichaelNorton, BenjaminTelese, AndreaSimons-Linares, RobertoHaidry, Rehan2025-07-032025-07-032024-06-20Papaefthymiou, A., Aslam, N., Hussein, M., Alzoubaidi, D., Gross, S. A., Serna, A., Varbobitis, I., Hengehold, T. A., López, M. F., Fernández-Sordo, J. O., Rey, J. W., Hayee, B., Despott, E. J., Murino, A., Moreea, S., Boger, P., Dunn, J. M., Mainie, I., Mullady, D., Early, D., … Haidry, R. (2024). Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study. Annals of gastroenterology, 37(4), 418–426. https://doi.org/10.20524/aog.2024.089710.20524/aog.2024.0897https://hdl.handle.net/20.500.14709/204Background: Hemostatic powders are used as second-line treatment in acute gastrointestinal (GI) bleeding (AGIB). Increasing evidence supports the use of TC-325 as monotherapy in specific scenarios. This prospective, multicenter study evaluated the performance of TC-325 as monotherapy for AGIB. Methods: Eighteen centers across Europe and USA contributed to a registry between 2016 and 2022. Adults with AGIB were eligible, unless TC-325 was part of combined hemostasis. The primary endpoint was immediate hemostasis. Secondary outcomes were rebleeding and mortality. Associations with risk factors were investigated (statistical significance at P≤0.05). Results: One hundred ninety patients were included (age 51-81 years, male: female 2:1), with peptic ulcer (n=48), upper GI malignancy (n=79), post-endoscopic treatment hemorrhage (n=37), and lower GI lesions (n=26). The primary outcome was recorded in 96.3% (95% confidence interval [CI]: 92.6-98.5) with rebleeding in 17.4% (95%CI 11.9-24.1); 9.9% (95%CI 5.8-15.6) died within 7 days, and 21.7% (95%CI 15.6-28.9) within 30 days. Regarding peptic ulcer, immediate hemostasis was achieved in 88% (95%CI 75-95), while 26% (95%CI 13-43) rebled. Higher ASA score was associated with mortality (OR 23.5, 95%CI 1.60-345; P=0.02). Immediate hemostasis was achieved in 100% of cases with malignancy and post-intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received TC-325 for lower GI bleeding, and in all but one the primary outcome was achieved. Conclusions: TC-325 monotherapy is safe and effective, especially in malignancy or post-endoscopic intervention bleeding. In patients with peptic ulcer, it could be helpful when the primary treatment is unfeasible, as bridge to definite therapy.enCC BY-NC-SA 4.0https://creativecommons.org/licenses/by-nc-sa/4.0/deed.enGastroenterologyEndoscopyJournal Articlehttps://gerr.openrepository.com/bitstreams/b7a6d4b6-cb32-4100-b8c6-e574a0344333/download