Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy.
Adult
Aged
Aged, 80 and over
Canada
Cecal Diseases
/ therapy
Colonic Diseases
/ therapy
Colonic Polyps
/ surgery
Colonoscopy
Female
Gastrointestinal Hemorrhage
/ therapy
Hemostasis, Endoscopic
/ methods
Hemostatics
/ therapeutic use
Humans
Intestinal Diseases
/ therapy
Male
Middle Aged
Minerals
/ therapeutic use
Mortality
Postoperative Hemorrhage
/ therapy
Prospective Studies
Rectal Diseases
/ therapy
Recurrence
Treatment Outcome
Journal
Gastrointestinal endoscopy
ISSN: 1097-6779
Titre abrégé: Gastrointest Endosc
Pays: United States
ID NLM: 0010505
Informations de publication
Date de publication:
04 2019
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
865-871Informations de copyright
Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.