Ballester R, Costigan C, O'Sullivan AM, Sengupta S, McNamara D. Efficacy and applications for PuraStat® use in the management of unselected gastrointestinal bleeding: A retrospective observational study. World J Gastrointest Endosc 2025; 17(3): 98021 [DOI: 10.4253/wjge.v17.i3.98021]
Corresponding Author of This Article
Raquel Ballester, MD, Department of Gastroenterology, Tallaght University Hospital, Belgard Road, Dublin D24, Ireland. ballestr@tcd.ie
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Retrospective Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Raquel Ballester, Conor Costigan, Aoife Mary O'Sullivan, Shreyashee Sengupta, Deirdre McNamara, Department of Gastroenterology, Tallaght University Hospital, Dublin D24, Ireland
Raquel Ballester, Conor Costigan, Deirdre McNamara, Trinity Academic Gastroenterology Group, School of Medicine - Trinity College Dublin, Dublin D2, Ireland
Co-first authors: Raquel Ballester and Deirdre McNamara.
Author contributions: Ballester R and McNamara D designed the study; Ballester R, Costigan C, O’Sullivan AM, Sengupta S and McNamara D recruited data; Ballester R and McNamara D analyzed and interpreted data; Ballester R wrote the manuscript; McNamara D assessed and verified the study data; All authors critically reviewed and provided final approval of the manuscript, and all authors were responsible for the decision to submit the manuscript for publication.
Institutional review board statement: This study was approved by the Saint James’s Hospital and Tallaght University Hospital Joint Research and Ethics Committee (No. 2395), Dublin, Ireland.
Informed consent statement: The requirement for the acquisition of informed consent from patients was waived owing to the retrospective nature of the study.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No additional data are available.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Raquel Ballester, MD, Department of Gastroenterology, Tallaght University Hospital, Belgard Road, Dublin D24, Ireland. ballestr@tcd.ie
Received: June 15, 2024 Revised: November 11, 2024 Accepted: February 8, 2025 Published online: March 16, 2025 Processing time: 271 Days and 18.3 Hours
Abstract
BACKGROUND
Hemostatic powders have been used as primary or salvage therapy to control gastrointestinal bleeding in a number of scenarios. PuraStat® is a novel, self-assembling peptide gel that has properties that differ from hemostatic powders. It is transparent, can be used in narrow spaces and combined with other modalities. Also, it is pre-filled in a syringe ready to use and easy to handle and deliver. PuraStat® has been shown to be effective and safe in treating gastrointestinal bleeding lesions. But, its role as a hemostatic agent in all bleeding indications remains to be clarified.
AIM
To evaluate PuraStat® efficacy and its applications, feasibility and safety in treating gastrointestinal bleeding lesions.
METHODS
We performed a retrospective single-centre analysis of all consecutive patients with gastrointestinal bleeding, that required endoscopic treatment and where PuraStat® was applied, from June 2020 to October 2022. Demographics, biochemical, endoscopic, endoscopist assessment and outcome data were collected. We analysed the whole cohort and the subgroup with upper gastrointestinal bleeding. The primary outcome was to evaluate the efficacy of PuraStat® at achieving initial hemostasis. The patients were followed–up for 30 days after the episode of bleeding.
RESULTS
In total 45 patients were included, and 17/45 (37.8%) females. The mean age was 65.8 years. Charlson score was > 2 in 27/45 (60%) and 26/45 (57.8%) required transfusion. The procedures were gastroscopy (77.8%), colonoscopy (15.5%), endoscopic retrograde cholangiopancreatography (4.4%) and enteroscopy (2.2%). The most common bleeding lesion was peptic ulcer (33.3%). PuraStat® was used alone in 36% of the cases. One hundred percent achieved initial hemostasis and no complications were documented. There were no significant differences between the use of PuraStat® alone or in combination in terms of re-bleeding (P = 0.64) or mortality (P = 0.69). In 46.6% of cases, the reason for applying PuraStat® was as addition to standard of care, in 35.5% as an alternative because standard of care was not possible and in 17.8% as a rescue therapy.
CONCLUSION
PuraStat® is an effective therapy for multiple etiologies and is considered very easy to use in the majority. Its role as front line agent should be considered in the future.
Core Tip: This study shows that PuraStat® is safe, effective and easy to use as hemostatic agent in multiple gastrointestinal bleeding sources, including lesions responsible for upper gastrointestinal bleeding. This is significant because many times, the standard of care treatment, such as sclerosant agents, hemoclips or soft coagulation forceps are not available or cannot be applied due to the lesions are placed in difficult positions, or there is underlying fibrosis of a diffuse bleeding.
