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Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder

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ClinicalTrials.gov Identifier: NCT03066700
Recruitment Status : Not yet recruiting
First Posted : February 28, 2017
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

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.

Condition or disease Intervention/treatment
Death Device: Hemostatic powder

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Prognostic Factors of Outcome in Patient With Malignant Gastrointestinal Bleeding Treated With a Novel Hemostatic Power
Estimated Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 1, 2017
Estimated Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hemospray application
The patients with GI bleeding from tumor and received Hemospray as a hemostasis method.
Device: Hemostatic 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.
Other Name: HemosprayTM




Primary Outcome Measures :
  1. Mortality rate [ Time Frame: 6 months ]
    Death rate after applying HemosprayTM


Secondary Outcome Measures :
  1. Rebleeding rate [ Time Frame: 30 days ]
    Bleeding from tumor after applying HemosprayTM



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066700


Contacts
Contact: Rapat Pittayanon 022564356 rapat125@gmail.com

Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
McGill University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rapat Pittayanon, MD, Principle investigator, Gastrointestinal Unit, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT03066700     History of Changes
Other Study ID Numbers: RP012
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemostatics
Coagulants