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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01078324
First Posted: March 2, 2010
Last Update Posted: August 19, 2016
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.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of California, Los Angeles
  Purpose
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
Colitis, Ischemic

Study Type: Observational
Study Design: 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

Further study details as provided by University of California, Los Angeles:

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

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

Enrollment: 550
Study Start Date: December 1997
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ischemic colitis
Ischemic colitis, Diverticulosis

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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
  Contacts and Locations
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


Locations
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)
Investigators
Principal Investigator: Dennis M Jensen, M.D. University of California, Los Angeles
  More Information

Publications:
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 Submitted: March 1, 2010
First Posted: March 2, 2010
Last Update Posted: August 19, 2016
Last Verified: August 2016

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