Evidence map›Paper›PMID 34129089›Full record

Observational studySurgical endoscopy2022

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

Federica Branchi, Rolf Klingenberg-Noftz, Kristina Friedrich, Nataly Bürgel, Severin Daum, Juliane Buchkremer, Elena Sonnenberg, Michael Schumann, Christoph Treese, Hanno Tröger and 19 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Surgical endoscopy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06698419 (A Prospective Study), which is not on this map. Cited by 51 papers.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06698419 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

A Prospective Study: The Effect of RADA16 on Mastoid Cavity Epithelialization After Canal Wall Down Mastoidectomy

TypeinterventionalSponsorUniversity of FloridaRan2025 to 2027Enrolled14ConditionsDelayed Wound HealingArmsRADA16 gel application into mastoid cavity
3 · Its place in the literature

Who cites it

51 citing papers in PubMed.

  1. Trial
  2. Review
  3. Observational
  4. Article
  5. Efficacy and safety of PuraStatSurgery today · 2026
    Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Hemostasis: Role of PuraStatWorld journal of gastrointestinal endoscopy · 2025
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Federica BranchiCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Rolf Klingenberg-NoftzDRK-Krankenhaus Grevesmühlen, Gastroenterologie und Allgemeine Innere Medizin, Klützer Straße 13-15, 23936, Grevesmühlen, Germany.
Kristina FriedrichCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Nataly BürgelCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Severin DaumCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Juliane BuchkremerCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Elena SonnenbergCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Michael SchumannCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Christoph TreeseCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Hanno TrögerCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Donata LissnerCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Hans-Jörg EppleCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Britta SiegmundCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Andrea StrouxInstitut für Biometrie und Klinische Epidemiologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12200, Berlin, Germany.
Andreas AdlerCampus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Gastroenterologie und Hepatologie, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Winfried Veltzke-SchliekerCampus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Gastroenterologie und Hepatologie, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Daniel AutenriethCampus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Gastroenterologie und Hepatologie, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Silke LeonhardtCampus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Gastroenterologie und Hepatologie, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Andreas FischerCampus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Gastroenterologie und Hepatologie, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Christian JürgensenCampus Mitte, Medizinische Klinik mit Schwerpunkt Gastroenterologie und Hepatologie, Virchowweg 10, 10117, Berlin, Germany.
Ulrich-Frank PapeCampus Mitte, Medizinische Klinik mit Schwerpunkt Gastroenterologie und Hepatologie, Virchowweg 10, 10117, Berlin, Germany.
Bertram WiedenmannCampus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Gastroenterologie und Hepatologie, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Oliver MöschlerNiels-Stensen-Kliniken, Marienhospital Osnabück GmbH, Bischhofstraße 1, 49074, Osnabrück, Germany.
Maximilian SchreinerBundeswehrkrankenhaus Berlin, Klinik für Innere Medizin, Scharnhorststraße 13, 10115, Berlin, Germany.
Mathias Z StrowskiPark-Klinik Weißensee, Gastroenterologie und Onkologie, Klinik für Innere Medizin, Schönstr. 80, 13086, Berlin, Germany.
Volkmar HempelKlinikum Mittleres Erzgebirge gGmbH, Klinik für Innere Medizin, Alte Marienberger Straße 52, 09405, Zschopau, Germany.
Yvonne HuberI. Medizinische Klinik Und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, 55131, Mainz, Germany.
Helmut NeumannI. Medizinische Klinik Und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, 55131, Mainz, Germany.
Christian BojarskiCampus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité-Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany. christian.bojarski@charite.de.ORCID 0000-0001-7533-672X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA 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.

methodsIn 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.

results111 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.

conclusionsPuraStat 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.

Indexed as

Hemostasis, EndoscopicHemostaticsGastrointestinal HemorrhageHumansPilot ProjectsProspective StudiesTreatment OutcomeHemostaticsGastrointestinal bleedingHaemostasisPuraStat

Identifiers

PMID34129089
PMCPMC9001238

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.