title: A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry).
abstract: Background and study aims:The hemostatic powder TC-325 (Hemospray; Cook Medical, Winston-Salem, North Carolina, USA) has shown promising results in the treatment of upper gastrointestinal bleeding (UGIB) in expert centers in pilot studies. The aim of this study was to evaluate the feasibility and efficacy of TC-325 in a large prospective registry of use in routine practice.Patients and methods:The data of all patients treated with TC-325 were prospectively collected through a national registry. Outcomes were the immediate feasibility and efficacy of TC-325 application, as well as the rates of rebleeding at Day 8 and Day 30. Multivariate analysis was performed to determine predictive factors of rebleeding.Results:A total of 202 patients were enrolled and 64 endoscopists participated from 20 centers. TC-325 was used as salvage therapy in 108 patients (53.5 %). The etiology of bleeding was an ulcer in 75 patients (37.1 %), tumor in 61 (30.2 %), postendoscopic therapy in 35 (17.3 %), or other in 31 (15.3 %). Application of the hemostatic powder was found to be very easy or easy in 31.7 % and 55.4 %, respectively. The immediate efficacy rate was 96.5 %. Recurrence of UGIB was noted at Day 8 and Day 30 in 26.7 % and 33.5 %, respectively. Predictive factors of recurrence at Day 8 were melena at initial presentation and use of TC-325 as salvage therapy.Conclusion:These multicenter data confirmed the high rate of immediate hemostasis, excellent feasibility, and good safety profile of TC-325, which could become the treatment of choice in bleeding tumors or postendoscopic bleeding but not in bleeding ulcers where randomized studies are needed.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT02595853).
authors.affiliation: Institut des Maladies de l'Appareil Digestif, University Hospital, Nantes, France.
authors.forename: Sami
authors.initials: S
authors.lastname: Haddara
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Dupuytren, Limoges, France.
authors.forename: Jeremie
authors.initials: J
authors.lastname: Jacques
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Charles Nicolle, Rouen, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Lecleire
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Lille, Lille, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Branche
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Cochin, Paris, France.
authors.forename: Sarah
authors.initials: S
authors.lastname: Leblanc
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Henri-Mondor, Paris, France.
authors.forename: Yann
authors.initials: Y
authors.lastname: Le Baleur
authors.affiliation: Service d'Hépato-gastro-entérologie, CH Vichy, Vichy, France.
authors.forename: Jocelyn
authors.initials: J
authors.lastname: Privat
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU La Timone, Marseille, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Heyries
authors.affiliation: Service d'Hépato-gastro-entérologie, Hopitaux Universitaires de Genève, Geneva, Switzerland.
authors.forename: Philippe
authors.initials: P
authors.lastname: Bichard
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU La Timone, Marseille, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Granval
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Saint-Antoine, Paris, France.
authors.forename: Ulriikka
authors.initials: U
authors.lastname: Chaput
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Besançon, Besançon, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Koch
authors.affiliation: Clinique des Cèdres, Cornebarrieu, France.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Levy
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Tours, Tours, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Godart
authors.affiliation: Service d'Hépato-gastro-entérologie, CH Princesse Grace, Monaco.
authors.forename: Antoine
authors.initials: A
authors.lastname: Charachon
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Caremeau, Nîmes, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Bourgaux
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Angers, Angers, France.
authors.forename: Elodie
authors.initials: E
authors.lastname: Metivier-Cesbron
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU Bordeaux, Bordeaux, France.
authors.forename: Edouard
authors.initials: E
authors.lastname: Chabrun
authors.affiliation: Service d'Hépato-gastro-entérologie, CH Saint-Brieuc, Saint-Brieuc, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Quentin
authors.affiliation: EA 4275, Biostatistics, Pharmacoepidemiology and Subjective Measures in Health Sciences, University of Nantes, Nantes, France.
authors.forename: Bastien
authors.initials: B
authors.lastname: Perrot
authors.affiliation: Service d'Hépato-gastro-entérologie, CHU L'Archet, Nice, France.
authors.forename: Geoffroy
authors.initials: G
authors.lastname: Vanbiervliet
authors.affiliation: Institut des Maladies de l'Appareil Digestif, University Hospital, Nantes, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Coron
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016099:Endoscopy, Gastrointestinal / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000209:etiology / Q000628:therapy*; D005770:Gastrointestinal Neoplasms / Q000150:complications*; D016558:Hemostasis, Endoscopic; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000627:therapeutic use*; D010437:Peptic Ulcer / Q000150:complications; D011208:Powders / Q000627:therapeutic use; D011446:Prospective Studies; D012008:Recurrence; D012042:Registries; D012307:Risk Factors
chemical_list: D006490:Hemostatics; D008903:Minerals; D011208:Powders; C581750:hemospray