Study of Ischemic Colitis Compared to Other Diagnoses in Patients With Lower Gastrointestinal Bleeding

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01078324
First received: March 1, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted

March 1, 2010
March 1, 2010
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The clinical course and outcomes of the ischemic colitis group compared to other colonic diagnoses group [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Study of Ischemic Colitis Compared to Other Diagnoses in Patients With Lower Gastrointestinal Bleeding
Ischemic Colitis Is a Common Cause of Severe Hematochezia and Patient Outcomes Are Worse Than With Other Colonic Diagnoses

The purpose of this study is to study the demographic,laboratory,endoscopic, and outcomes of ischemic colitis patient presented with severe lower gastrointestinal bleeding compared to other diagnoses.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients who were admitted into the hospital

Colitis, Ischemic
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Ischemic colitis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
550
December 2009
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Inclusion Criteria:

  • bright red blood clots or burgundy colored stool documented by a health care worker
  • clinical or laboratory evidence of significant blood loss, manifested by any one of the following: (a) more than three bloody bowel movements in eight hours (b) a decrease of two grams of hemoglobin (Hgb) from baseline, or (c) transfusion of more than three units of red blood cell (URBC).

Exclusion Criteria:

  • age less than 18 year
  • history of inflammatory bowel disease
  • hypotension or shock refractory to resuscitation
  • severe coagulopathy refractory to resuscitation (platelet count < 30,000; prothrombin time [PT]- more than 2 times normal; partial thromboplastin time [PTT]- more than 2 times normal)
  • acquired immune deficiency syndrome or neutropenia
  • the inability to provide informed consent
  • documentation of anal disorders as a cause of bleeding such as internal hemorrhoids, anal fissures, polyps or cancer of the anal canal, and fistulae
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01078324
03-11-115-12, K24DK002650
No
Dennis Jensen, M.D., University of California, Los Angeles
University of California, Los Angeles
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Dennis M Jensen, M.D. University of California, Los Angeles
University of California, Los Angeles
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP