Surgicel® (Fibrillar) in Non-variceal UGI Bleeding

Non-variceal Upper Gastrointestinal Bleeding Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02054260
• Other study ID #: SCHBC_IRB_2013-40
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2014
• Last updated: November 18, 2014

Study information

• Verified date: November 2014
• Source: Soonchunhyang University Hospital
• Contact: Su Jin Hong, MD, PhD
• Phone: +82-32-621-5087
• Email: sjhong[@]schmc.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: December 2015
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Non-variceal Upper Gastrointestinal Bleeding

Intervention

Drug:
• Surgicel

Locations

Country	Name	City	State
Korea, Republic of	Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine	Bucheon

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rebleeding rate at the second look endoscopy		2 year