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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03066700

Enrollment

Registered

2017-02-28

Start date

2017-03-01

Completion date

2017-08-31

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death

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.

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.

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.

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mortality rate	6 months	Death rate after applying HemosprayTM

Secondary

Measure	Time frame	Description
Rebleeding rate	30 days	Bleeding from tumor after applying HemosprayTM

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026