Evidence map›Paper›PMID 38974074›Full record

ArticleAnnals of gastroenterology

Hemospray® (hemostatic powder TC-325) as monotherapy for acute gastrointestinal bleeding: a multicenter prospective study.

Apostolis Papaefthymiou, Nasar Aslam, Mohamed Hussein, Durayd Alzoubaidi, Seth A Gross, Alvaro De La Serna, Ioannis Varbobitis, Tricia A Hengehold, Miguel Fraile López, Jacobo Ortiz Fernández-Sordo and 24 more

Abstract read
In one paragraph

Article in Annals of gastroenterology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Hemostasis: Role of PuraStatWorld journal of gastrointestinal endoscopy · 2025
    Article
  3. 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

34 authors.

Apostolis PapaefthymiouDigestive Diseases and Surgery institute, Cleveland Clinic, London, UK (Apostolis Papaefthymiou, Alberto Murino, Benjamin Norton, Andrea Telese, Rehan Haidry).
Nasar AslamDepartment of Gastrointestinal Services, University College London Hospitals NHS Foundation Trust, London, UK (Nasar Aslam, Rehan Haidry).
Mohamed HusseinDivision of Surgery and Interventional Sciences, University College London, UK (Mohamed Hussein, Durayd Alzoubaidi, Andrea Telese, Rehan Haidry).
Durayd AlzoubaidiDivision of Surgery and Interventional Sciences, University College London, UK (Mohamed Hussein, Durayd Alzoubaidi, Andrea Telese, Rehan Haidry).
Seth A GrossNYU Langone, New York, USA (Seth A. Gross, Melissa Latorre, Michael O'Donnell).
Alvaro De La SernaDepartment of Gastroenterology and Hepatology, Ramon y Cajal University Hospital, IRYCIS, CIBEREHD, University of Alcala, Madrid, Spain (Alvaro De La Serna, Enrique Rodríguez De Santiago).
Ioannis VarbobitisNIHR Nottingham Digestive Diseases Biomedical Research Centre, Nottingham University Hospitals, Nottingham, UK (Ioannis Varbobitis, Jacobo Ortiz Fernández-Sordo, Krish Ragunath).
Tricia A HengeholdDepartment of Gastroenterology, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA (Tricia A. Hengehold, Daniel Mullady, Dayna Early).
Miguel Fraile LópezGastroenterology and Hepatology Department, Clinical and Translational Research in Digestive Diseases, Valdecilla Research Institute (IDIVAL), Marqués de Valdecilla University Hospital, Santander, Spain (Miguel Fraile López).
Jacobo Ortiz Fernández-SordoNIHR Nottingham Digestive Diseases Biomedical Research Centre, Nottingham University Hospitals, Nottingham, UK (Ioannis Varbobitis, Jacobo Ortiz Fernández-Sordo, Krish Ragunath).
Johannes W ReyDepartment of Gastroenterology, Osnabrück Clinic, Osnabrück, Germany (Johannes W. Rey).
Bu HayeeDepartment of Gastroenterology, Kings College Hospital, London, UK (Bu Hayee).
Edward J DespottRoyal Free Unit for Endoscopy and Centre for Gastroenterology, Royal Free NHS Foundation Trust, London, UK (Edward J. Despott, Alberto Murino).
Alberto MurinoDigestive Diseases and Surgery institute, Cleveland Clinic, London, UK (Apostolis Papaefthymiou, Alberto Murino, Benjamin Norton, Andrea Telese, Rehan Haidry).
Sulleman MoreeaDepartment of Gastroenterology, Bradford Teaching Hospitals Foundation Trust, Bradford, UK (Sulleman Moreea).
Phil BogerDepartment of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK (Phil Boger).
Jason M DunnDepartment of Gastroenterology, Guy's and St Thomas' Foundation Trust, London, UK (Jason M. Dunn).
Inder MainieDepartment of Gastroenterology, Belfast Health and Social Care Trust, Belfast, UK (Inder Mainie).
Daniel MulladyDepartment of Gastroenterology, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA (Tricia A. Hengehold, Daniel Mullady, Dayna Early).
Dayna EarlyDepartment of Gastroenterology, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA (Tricia A. Hengehold, Daniel Mullady, Dayna Early).
Melissa LatorreNYU Langone, New York, USA (Seth A. Gross, Melissa Latorre, Michael O'Donnell).
Krish RagunathNIHR Nottingham Digestive Diseases Biomedical Research Centre, Nottingham University Hospitals, Nottingham, UK (Ioannis Varbobitis, Jacobo Ortiz Fernández-Sordo, Krish Ragunath).
John T AndersonDepartment of Gastroenterology, Gloucestershire Hospitals NHS Foundation Trust - Cheltenham General Hospital, Cheltenham, UK (John T. Anderson).
Pradeep BhandariDepartment of Gastroenterology, Portsmouth Hospitals NHS Trust, Portsmouth, UK (Pradeep Bhandari).
Martin GoetzSindelfingen-Böblingen Clinic, Böblingen, Germany (Martin Goetz).
Ralf KiesslichHorst Schmidt Clinics, Wiesbaden, Germany (Ralf Kiesslich).
Emmanuel CoronDepartment of Gastroenterology, University Hospital Center, Nantes, France (Emmanuel Coron).
Enrique Rodríguez De SantiagoDepartment of Gastroenterology and Hepatology, Ramon y Cajal University Hospital, IRYCIS, CIBEREHD, University of Alcala, Madrid, Spain (Alvaro De La Serna, Enrique Rodríguez De Santiago).
Tamas A GondaColumbia University Medical Centre, New York, USA (Tamas A. Gonda).
Michael O'DonnellNYU Langone, New York, USA (Seth A. Gross, Melissa Latorre, Michael O'Donnell).
Benjamin NortonDigestive Diseases and Surgery institute, Cleveland Clinic, London, UK (Apostolis Papaefthymiou, Alberto Murino, Benjamin Norton, Andrea Telese, Rehan Haidry).
Andrea TeleseDigestive Diseases and Surgery institute, Cleveland Clinic, London, UK (Apostolis Papaefthymiou, Alberto Murino, Benjamin Norton, Andrea Telese, Rehan Haidry).
Roberto Simons-LinaresGastroenterology and Hepatology Department, Digestive Disease Institute, Cleveland Clinic, Cleveland, OH, USA (Roberto Simons-Linares).
Rehan HaidryDigestive Diseases and Surgery institute, Cleveland Clinic, London, UK (Apostolis Papaefthymiou, Alberto Murino, Benjamin Norton, Andrea Telese, Rehan Haidry).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Hemostatic powders are used as second-line treatment in acute gastrointestinal (GI) bleeding (AGIB). Increasing evidence supports the use of TC-325 as monotherapy in specific scenarios. This prospective, multicenter study evaluated the performance of TC-325 as monotherapy for AGIB. Methods: Eighteen centers across Europe and USA contributed to a registry between 2016 and 2022. Adults with AGIB were eligible, unless TC-325 was part of combined hemostasis. The primary endpoint was immediate hemostasis. Secondary outcomes were rebleeding and mortality. Associations with risk factors were investigated (statistical significance at P≤0.05). Results: One hundred ninety patients were included (age 51-81 years, male: female 2:1), with peptic ulcer (n=48), upper GI malignancy (n=79), post-endoscopic treatment hemorrhage (n=37), and lower GI lesions (n=26). The primary outcome was recorded in 96.3% (95% confidence interval [CI]: 92.6-98.5) with rebleeding in 17.4% (95%CI 11.9-24.1); 9.9% (95%CI 5.8-15.6) died within 7 days, and 21.7% (95%CI 15.6-28.9) within 30 days. Regarding peptic ulcer, immediate hemostasis was achieved in 88% (95%CI 75-95), while 26% (95%CI 13-43) rebled. Higher ASA score was associated with mortality (OR 23.5, 95%CI 1.60-345; P=0.02). Immediate hemostasis was achieved in 100% of cases with malignancy and post-intervention bleeding, with rebleeding in 17% and 3.1%, respectively. Twenty-six patients received TC-325 for lower GI bleeding, and in all but one the primary outcome was achieved. Conclusions: TC-325 monotherapy is safe and effective, especially in malignancy or post-endoscopic intervention bleeding. In patients with peptic ulcer, it could be helpful when the primary treatment is unfeasible, as bridge to definite therapy.

Indexed as

endoscopyHemospray®TC-325upper gastrointestinal bleeding

Identifiers

PMID38974074
PMCPMC11226744

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

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.