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Surgicel® (Fibrillar) in Non-variceal UGI Bleeding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054260
Recruitment Status : Unknown
Verified November 2014 by Su Jin Hong, Soonchunhyang University Hospital.
Recruitment status was:  Recruiting
First Posted : February 4, 2014
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Su Jin Hong, Soonchunhyang University Hospital

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

Condition or disease Intervention/treatment Phase
Non-variceal Upper Gastrointestinal Bleeding Drug: Surgicel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgicel add therapy Drug: Surgicel



Primary Outcome Measures :
  1. Rebleeding rate at the second look endoscopy [ Time Frame: 2 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054260


Contacts
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Contact: Su Jin Hong, MD, PhD +82-32-621-5087 sjhong@schmc.ac.kr

Locations
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Korea, Republic of
Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine Recruiting
Bucheon, Korea, Republic of, 420-767
Contact: Su Jin Hong, MD, PhD    +82-32-621-5087    sjhong@schmc.ac.kr   
Sponsors and Collaborators
Soonchunhyang University Hospital

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Responsible Party: Su Jin Hong, Professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT02054260    
Other Study ID Numbers: SCHBC_IRB_2013-40
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases