Endoscopy 2016; 48(12): 1084-1095
DOI: 10.1055/s-0042-116148
Original article
© Georg Thieme Verlag KG Stuttgart · New York

A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the “GRAPHE” registry)

Sami Haddara*
1   Institut des Maladies de l’Appareil Digestif, University Hospital, Nantes, France
Jeremie Jacques*
2   Service d’Hépato-gastro-entérologie, CHU Dupuytren, Limoges, France
Stéphane Lecleire
3   Service d’Hépato-gastro-entérologie, CHU Charles Nicolle, Rouen, France
Julien Branche
4   Service d’Hépato-gastro-entérologie, CHU Lille, Lille, France
Sarah Leblanc
5   Service d’Hépato-gastro-entérologie, CHU Cochin, Paris, France
Yann Le Baleur
6   Service d’Hépato-gastro-entérologie, CHU Henri-Mondor, Paris, France
Jocelyn Privat
7   Service d’Hépato-gastro-entérologie, CH Vichy, Vichy, France
Laurent Heyries
8   Service d’Hépato-gastro-entérologie, CHU La Timone, Marseille, France
Philippe Bichard
9   Service d’Hépato-gastro-entérologie, Hopitaux Universitaires de Genève, Geneva, Switzerland
Philippe Granval
8   Service d’Hépato-gastro-entérologie, CHU La Timone, Marseille, France
Ulriikka Chaput
10   Service d’Hépato-gastro-entérologie, CHU Saint-Antoine, Paris, France
Stephane Koch
11   Service d’Hépato-gastro-entérologie, CHU Besançon, Besançon, France
Jonathan Levy
12   Clinique des Cèdres, Cornebarrieu, France
Bruno Godart
13   Service d’Hépato-gastro-entérologie, CHU Tours, Tours, France
Antoine Charachon
14   Service d’Hépato-gastro-entérologie, CH Princesse Grace, Monaco
Jean-François Bourgaux
15   Service d’Hépato-gastro-entérologie, CHU Caremeau, Nîmes, France
Elodie Metivier-Cesbron
16   Service d’Hépato-gastro-entérologie, CHU Angers, Angers, France
Edouard Chabrun
17   Service d’Hépato-gastro-entérologie, CHU Bordeaux, Bordeaux, France
Vincent Quentin
18   Service d’Hépato-gastro-entérologie, CH Saint-Brieuc, Saint-Brieuc, France
Bastien Perrot
19   EA 4275, Biostatistics, Pharmacoepidemiology and Subjective Measures in Health Sciences, University of Nantes, Nantes, France
Geoffroy Vanbiervliet
20   Service d’Hépato-gastro-entérologie, CHU L’Archet, Nice, France
Emmanuel Coron
1   Institut des Maladies de l’Appareil Digestif, University Hospital, Nantes, France
21   Inserm Unit 913, University of Nantes, Nantes, France
› Author Affiliations
Further Information

Publication History

submitted 09 April 2016

accepted after revision 22 July 2016

Publication Date:
19 October 2016 (online)

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.

Trial registration: ClinicalTrials.gov (NCT02595853)

* These authors contributed equally to this work.