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CompletedNCT03066700Updated Feb 28, 2019

Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder

An observational study in Death, sponsored by King Chulalongkorn Memorial Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-28.

Sponsored by King Chulalongkorn Memorial Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study summary

This is a retrospective study to identify the prognostic factors of the good outcomes in patients who presented with upper GI bleeding from tumor and received Hemospray via endoscopy for hemostatic control. The good outcomes were assessed by immediate hemostasis, rebleeding at 72 hours as well as 7, 14 and 30 days following presentation at initial bleeding episode and also 6-month survival rate.

Read the detailed description

Tumor-related gastrointestinal (GI) bleeding is increasing due to the advancement of treatment in oncology. However, conventional endoscopic hemostatic methods are not reliable to control bleeding. Surgery, embolization, and radiotherapy can served as the salvage hemostasis; though, a bridging endoscopic therapy is required during resuscitation and stabilization of the patients. Hemospray is a recent novel endoscopic hemostatis powder which has a trend to be an effective instrument for controlling the active upper GI tumor bleeding from a match-pair, case-control study by the author's recent publication. Consequently, the authors hypothesized that there are some prognostic factors related to the outcome of Hemospray treatment in tumor bleeding.

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Conditions studied

  • Death
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In context

Lead sponsor

King Chulalongkorn Memorial Hospital is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cases will have been treated at the McGill University Health Centre in Montreal, Canada (MUHC; Royal Victoria Hospital - RVH and Montreal General Hospital - MGH sites) and King Chulalongkorn Memorial Hospital (KCMH), Chulalongkorn University, Bangkok, Thailand.

Inclusion criteria

  • All patients seen in the emergency room and/or hospitalized for malignant gastrointestinal haemorrhage from 2011 to 2017

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • Hemospray application

    The patients with GI bleeding from tumor and received Hemospray as a hemostasis method.

    Device: Hemostatic powder

Interventions

  • DeviceHemostatic powder

    HemosprayTM (Tc-325) is an endoscopic hemostatis powder that came onto market recently. It is made of an inorganic, non-absorbable powder which acts locally at the mucosa. When spraying the powder on to the bleeding site, it creates an adherent stable barrier sheath that allows for at least temporary hemostasis. Neither luminal nor systemic side effects have been reported to date.

    Also known as: HemosprayTM

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What researchers measure

Primary outcomes

  1. Mortality rate

    Death rate after applying HemosprayTM

    Time frame: 6 months

Secondary outcomes

  1. Rebleeding rate

    Bleeding from tumor after applying HemosprayTM

    Time frame: 30 days

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Study locations

1 site
  • King chulalongkorn memorial hospita
    Bangkok, Pathum Wan 10400, Thailand
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References and documents

Publications

  • Pittayanon R, Rerknimitr R, Barkun A. Prognostic factors affecting outcomes in patients with malignant GI bleeding treated with a novel endoscopically delivered hemostatic powder. Gastrointest Endosc. 2018 Apr;87(4):994-1002. doi: 10.1016/j.gie.2017.11.013. Epub 2017 Nov 20. PubMed 29158179 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03066700
Lead sponsor
King Chulalongkorn Memorial Hospital
Collaborators
McGill University
Responsible party
Rapat Pittayanon, MD (Principle investigator, Gastrointestinal Unit, King Chulalongkorn Memorial Hospital) — Principal investigator
First posted
Feb 28, 2017
Start date
Mar 1, 2017
Primary completion
Jun 1, 2017
Completion
Aug 31, 2017
Last update
Feb 28, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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