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

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ClinicalTrials.gov Identifier: NCT01078324
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : August 19, 2016
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of California, Los Angeles

Brief Summary:
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.

Condition or disease
Colitis, Ischemic

Detailed Description:
Secondary purpose of this study is to assess the risk factors for predicting diverticulosis versus ischemic colitis.

Study Type : Observational
Actual Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ischemic Colitis Is a Common Cause of Severe Hematochezia and Patient Outcomes Are Worse Than With Other Colonic Diagnoses
Study Start Date : December 1997
Primary Completion Date : December 2009
Study Completion Date : December 2009

Ischemic colitis
Ischemic colitis, Diverticulosis

Primary Outcome Measures :
  1. The clinical course and outcomes of the ischemic colitis group compared to other colonic diagnoses group [ Time Frame: 12 year period ]

Secondary Outcome Measures :
  1. Risk factors and prediction of ischemic colitis versus diverticulosis as the cause of severe hematochezia [ Time Frame: 12 year period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who were admitted into the hospital

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

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): NCT01078324

United States, California
The Veterans Affairs Greater Los Angeles Medical Center
Los Angeles, California, United States, 90073
Sponsors and Collaborators
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

Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01078324     History of Changes
Other Study ID Numbers: 03-11-115-12
K24DK002650 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Colitis, Ischemic
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Vascular Diseases
Cardiovascular Diseases