Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy.


Journal

Gastrointestinal endoscopy
ISSN: 1097-6779
Titre abrégé: Gastrointest Endosc
Pays: United States
ID NLM: 0010505

Informations de publication

Date de publication:
04 2019
Historique:
received: 01 08 2018
accepted: 16 10 2018
pubmed: 8 1 2019
medline: 17 9 2019
entrez: 8 1 2019
Statut: ppublish

Résumé

Acute lower GI bleeding is a frequent cause of hospital admission. The objective of this study was to evaluate the safety and performance of a hemostatic powder (TC-325/Hemospray) in the treatment of nonvariceal lower GI bleeding. Patients were enrolled into this prospective, multicenter, single-arm study at 4 tertiary care centers in Canada. Fifty patients with active lower GI bleeding of multiple different causes (52 bleeding sites) underwent topical endoscopic application of hemostatic powder. The primary endpoint was powder-related adverse events within 30 days of the index procedure. Secondary endpoints were initial hemostasis as well as recurrent bleeding and mortality within 30 days of the index procedure. Most patients (96%) had a single bleeding site, and most bleeding (73%) was due to polypectomy. Overall, the powder was applied as monotherapy in 13 bleeding sites (25%), as combination therapy in 22 bleeding sites (42.3%), and as rescue therapy in 17 bleeding sites (32.7%). Hemostasis was achieved in 98% of patients. No patient experienced a powder-related adverse event. Five patients (10%) developed recurrent bleeding within 30 days. One patient (2%) died within 30 days of powder application, but the death was not directly related to hemostatic powder use. The hemostatic powder is a safe and effective option for patients with lower GI bleeding of varying causes, and in particular, postpolypectomy hemorrhage. The hemostatic powder is effective as monotherapy, part of a combination approach, or as a rescue therapeutic option for the treatment of nonvariceal lower GI bleeding. (Clinical trial registration number: NCT02099435.).

Sections du résumé

BACKGROUND AND AIMS
Acute lower GI bleeding is a frequent cause of hospital admission. The objective of this study was to evaluate the safety and performance of a hemostatic powder (TC-325/Hemospray) in the treatment of nonvariceal lower GI bleeding.
METHODS
Patients were enrolled into this prospective, multicenter, single-arm study at 4 tertiary care centers in Canada. Fifty patients with active lower GI bleeding of multiple different causes (52 bleeding sites) underwent topical endoscopic application of hemostatic powder. The primary endpoint was powder-related adverse events within 30 days of the index procedure. Secondary endpoints were initial hemostasis as well as recurrent bleeding and mortality within 30 days of the index procedure.
RESULTS
Most patients (96%) had a single bleeding site, and most bleeding (73%) was due to polypectomy. Overall, the powder was applied as monotherapy in 13 bleeding sites (25%), as combination therapy in 22 bleeding sites (42.3%), and as rescue therapy in 17 bleeding sites (32.7%). Hemostasis was achieved in 98% of patients. No patient experienced a powder-related adverse event. Five patients (10%) developed recurrent bleeding within 30 days. One patient (2%) died within 30 days of powder application, but the death was not directly related to hemostatic powder use.
CONCLUSIONS
The hemostatic powder is a safe and effective option for patients with lower GI bleeding of varying causes, and in particular, postpolypectomy hemorrhage. The hemostatic powder is effective as monotherapy, part of a combination approach, or as a rescue therapeutic option for the treatment of nonvariceal lower GI bleeding. (Clinical trial registration number: NCT02099435.).

Identifiants

pubmed: 30612959
pii: S0016-5107(18)33202-4
doi: 10.1016/j.gie.2018.10.029
pii:
doi:

Substances chimiques

Hemostatics 0
Minerals 0
hemospray 0

Banques de données

ClinicalTrials.gov
['NCT02099435']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

865-871

Informations de copyright

Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Auteurs

Lawrence Hookey (L)

Hotel Dieu Hospital, Kingston, Ontario, Canada.

Alan Barkun (A)

Department of Medicine, Division of Gastroenterology, McGill University, Montreal, Quebec, Canada.

Richard Sultanian (R)

Division of Gastroenterology, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta Hospital, Edmonton, Alberta, Canada.

Robert Bailey (R)

Division of Gastroenterology, Royal Alexandra Hospital, Edmonton, Alberta, Canada.

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Classifications MeSH