NCT02054260

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

First QC Date

February 3, 2014

Last Update Submit

November 18, 2014

Conditions

Non-variceal Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

  • Rebleeding rate at the second look endoscopy

    2 year

Study Arms (1)

Surgicel add therapy

EXPERIMENTAL
Drug: Surgicel

Interventions

SurgicelDRUG
Surgicel add therapy

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with non variceal upper gastrointestinal bleeding proven by esophagogastroduodenoscopy
  • Patients with active bleeding (Forrest classification Ia or Ib or IIa)

You may not qualify if:

  • Patients with upper gastrointestinal tract malignancy
  • Patients with acute severe illness
  • Coagulopathy: liver cirrhosis, thrombocytopenia
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine

Bucheon-si, 420-767, South Korea

RECRUITING

MeSH Terms

Interventions

Surgicel

Central Study Contacts

Su Jin Hong, MD, PhD

CONTACT

+82-32-621-5087sjhong@schmc.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 4, 2014

Primary Completion

December 1, 2015

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

KR(1)