Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder
Prognostic Factors of Outcome in Patient With Malignant Gastrointestinal Bleeding Treated With a Novel Hemostatic Power
1 other identifier
observational
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedFebruary 28, 2019
February 1, 2019
3 months
February 23, 2017
February 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality rate
Death rate after applying HemosprayTM
6 months
Secondary Outcomes (1)
Rebleeding rate
30 days
Study Arms (1)
Hemospray application
The patients with GI bleeding from tumor and received Hemospray as a hemostasis method.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- All patients seen in the emergency room and/or hospitalized for malignant gastrointestinal haemorrhage from 2011 to 2017
You may not qualify if:
- Age \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King Chulalongkorn Memorial Hospitallead
- McGill Universitycollaborator
Study Sites (1)
King chulalongkorn memorial hospita
Bangkok, Pathum Wan, 10400, Thailand
Related Publications (1)
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.
PMID: 29158179DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator, Gastrointestinal Unit
Study Record Dates
First Submitted
February 23, 2017
First Posted
February 28, 2017
Study Start
March 1, 2017
Primary Completion
June 1, 2017
Study Completion
August 31, 2017
Last Updated
February 28, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share