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Observational Study
. 2022 May;36(5):2954-2961.
doi: 10.1007/s00464-021-08589-6. Epub 2021 Jun 15.

PuraStat in gastrointestinal bleeding: results of a prospective multicentre observational pilot study

Federica Branchi  1 , Rolf Klingenberg-Noftz  2 , Kristina Friedrich  1 , Nataly Bürgel  1 , Severin Daum  1 , Juliane Buchkremer  1 , Elena Sonnenberg  1 , Michael Schumann  1 , Christoph Treese  1 , Hanno Tröger  1 , Donata Lissner  1 , Hans-Jörg Epple  1 , Britta Siegmund  1 , Andrea Stroux  3 , Andreas Adler  4 , Winfried Veltzke-Schlieker  4 , Daniel Autenrieth  4 , Silke Leonhardt  4 , Andreas Fischer  4 , Christian Jürgensen  5 , Ulrich-Frank Pape  5 , Bertram Wiedenmann  4   5 , Oliver Möschler  6 , Maximilian Schreiner  7 , Mathias Z Strowski  8 , Volkmar Hempel  9 , Yvonne Huber  10 , Helmut Neumann  10 , Christian Bojarski  11
Affiliations
Observational Study

PuraStat in gastrointestinal bleeding: results of a prospective multicentre observational pilot study

Federica Branchi et al. Surg Endosc. 2022 May.

Abstract

Background: A recently developed haemostatic peptide gel for endoscopic application has been introduced to improve the management of gastrointestinal bleeding. The aim of this pilot study was to evaluate the feasibility, safety, efficacy and indication profiles of PuraStat in a clinical setting.

Methods: In this prospective observational multicentre pilot study, patients with acute non-variceal gastrointestinal bleeding (upper and lower) were included. Primary and secondary application of PuraStat was evaluated. Haemoglobin, prothrombin time, platelets and transfusion behaviour were documented before and after haemostasis. The efficacy of PuraStat was assessed during the procedure, at 3 days and 1 week after application.

Results: 111 patients with acute gastrointestinal bleeding were recruited into the study. 70 percent (78/111) of the patients had upper gastrointestinal bleeding and 30% (33/111) had lower gastrointestinal bleeding. After primary application of PuraStat, initial haemostatic success was achieved in 94% of patients (74/79, 95% CI 88-99%), and in 75% of the patients when used as a secondary haemostatic product, following failure of established techniques (24/32, 95% CI 59-91%). The therapeutic success rates (absence of rebleeding) after 3 and 7 days were 91% and 87% after primary use, and 87% and 81% in all study patients. Overall rebleeding rate at 30 day follow-up was 16% (18/111). In the 5 patients who finally required surgery (4.5%), PuraStat allowed temporary haemostasis and stabilisation.

Conclusions: PuraStat expanded the therapeutic toolbox available for an effective treatment of gastrointestinal bleeding sources. It could be safely applied and administered without complications as a primary or secondary therapy. PuraStat may additionally serve as a bridge to surgery in order to achieve temporary haemostasis in case of refractory severe bleeding, possibly playing a role in preventing immediate emergency surgery.

Keywords: Gastrointestinal bleeding; Haemostasis; PuraStat.

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Conflict of interest statement

Kristina Friedrich and Drs. Branchi, Klingenberg-Noftz, Bürgel, Daum, Buchkremer, Sonnenberg, Schumann, Treese, Tröger, Lissner, Epple, Stroux, Adler, Veltzke-Schlieker, Autenrieth, Leonhardt, Fischer, Jürgensen, Pape, Möschler, Schreiner, Hempel, Huber and Bojarski as well as Prof. Siegmund, Prof. Wiedenmann and Prof. Strowski have no conflicts of interest or financial ties to disclose. None of the authors has financial relationships with any pharmaceutical or device company.

Figures

Fig. 1
Fig. 1
A: PuraStat system ready-to-use. A 5 mL PuraStat syringe is connected with the application catheter (Image by courtesy of 3D Matrix UK, Ltd, London, UK)
Fig. 2
Fig. 2
Clinical application of PuraStat in different indications. A Duodenal ulcer with vessel and adherent clot. B Gastrointestinal stromal tumour in the proximal jejunum after oozing haemorrhage. C Duodenal ulcer with visible vessel, stabilisation of the endoscope with distal cap. D Oozing bleeding after polypectomy in the duodenum. E Tumour bleeding after duodenal infiltration of a pancreas tumour. F Duodenal ulcer with vessel and adherent clot
See this image and copyright information in PMC

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