Back to resultsSurgicel® (Fibrillar) in Non-variceal UGI Bleeding
Primary Purpose
Non-variceal Upper Gastrointestinal Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Surgicel
Sponsored by
About this trial
This is an interventional trial for Non-variceal Upper Gastrointestinal Bleeding
Eligibility Criteria
Inclusion Criteria:
- Patients with non variceal upper gastrointestinal bleeding proven by esophagogastroduodenoscopy
- Patients with active bleeding (Forrest classification Ia or Ib or IIa)
Exclusion Criteria:
- Patients with upper gastrointestinal tract malignancy
- Patients with acute severe illness
- Coagulopathy: liver cirrhosis, thrombocytopenia
- Pregnant women
Sites / Locations
- Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surgicel add therapy
Arm Description
Outcomes
Primary Outcome Measures
Rebleeding rate at the second look endoscopy
Secondary Outcome Measures
Full Information
NCT ID
NCT02054260
First Posted
February 3, 2014
Last Updated
November 18, 2014
Sponsor
Soonchunhyang University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02054260
Brief Title
Surgicel® (Fibrillar) in Non-variceal UGI Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soonchunhyang University Hospital
4. Oversight
5. Study Description
Brief Summary
The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-variceal Upper Gastrointestinal Bleeding
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Surgicel add therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Surgicel
Primary Outcome Measure Information:
Title
Rebleeding rate at the second look endoscopy
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria:
Patients with non variceal upper gastrointestinal bleeding proven by esophagogastroduodenoscopy
Patients with active bleeding (Forrest classification Ia or Ib or IIa)
Exclusion Criteria:
Patients with upper gastrointestinal tract malignancy
Patients with acute severe illness
Coagulopathy: liver cirrhosis, thrombocytopenia
Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Su Jin Hong, MD, PhD
Phone
+82-32-621-5087
Email
sjhong@schmc.ac.kr
Facility Information:
Facility Name
Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine
City
Bucheon
ZIP/Postal Code
420-767
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Jin Hong, MD, PhD
Phone
+82-32-621-5087
Email
sjhong@schmc.ac.kr
12. IPD Sharing Statement
Learn more about this trial
Surgicel® (Fibrillar) in Non-variceal UGI Bleeding
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