Efficacy and applications for PuraStat® use in the management of unselected gastrointestinal bleeding: A retrospective observational study.

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.