- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02820077
Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions
Randomized Controlled Trial of Hemostatic Powder Versus Optimal Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions
Study Overview
Status
Intervention / Treatment
Detailed Description
Gastrointestinal tumor bleeding is a challenging clinical condition with a high mortality rate. Several endoscopic hemostasis techniques have been tested, but results were disappointing. Re-bleeding and mortality rates are still high.
Hemostatic powder is a promising therapy for tumor bleeding, since it can be applied over large surfaces. Bleeding from a tumor lesion often occurs diffusely on the surface of the tumor rather than from a specific vessel.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any kind of malignancy
- Gastrointestinal bleeding in the last 48 hours
- Referred to emergency endoscopy
Exclusion Criteria:
- under 18 years old
- bleeding from non malignant lesions
- previous endoscopic treatment with another method done in the last 48h
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hemospray
Patients treated with hemostatic powder
|
Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards
|
No Intervention: Clinical support
Patients treated with optimal clinical management, as it is been advised by the latest guidelines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
rebleeding
Time Frame: until 30 days after endoscopy
|
until 30 days after endoscopy
|
mortality
Time Frame: until 30 days after endoscopy
|
until 30 days after endoscopy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Successful initial hemostasis
Time Frame: From the moment of the procedure until 24 hours after it
|
From the moment of the procedure until 24 hours after it
|
Hospital length of stay
Time Frame: from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months
|
from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP883/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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