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Completed

NCT Number: NCT03066700

Prognostic Factors in Malignant GI Bleeding Treated With Hemostatic Powder

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.

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Key information

Conditions

Death Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King chulalongkorn memorial hospita

Bangkok, Pathum Wan, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemostatic powder

Device

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 names: HemosprayTM

Primary outcomes

  1. Mortality rate

    Time frame: 6 months

    Death rate after applying HemosprayTM

Secondary outcomes

  1. Rebleeding rate

    Time frame: 30 days

    Bleeding from tumor after applying HemosprayTM

Sponsors and collaborators

Lead sponsor

King Chulalongkorn Memorial Hospital

Other

Collaborators

  • McGill University

Registry information

Official study title

Prognostic Factors of Outcome in Patient With Malignant Gastrointestinal Bleeding Treated With a Novel Hemostatic Power

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2017
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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