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
  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

Resource links provided by NLM:


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 [ Designated as safety issue: No ]

Enrollment: 550
Study Completion Date: December 2009
Groups/Cohorts
Ischemic colitis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Dennis M Jensen, M.D. University of California, Los Angeles
  More Information

Publications:
Responsible Party: Dennis Jensen, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01078324     History of Changes
Other Study ID Numbers: 03-11-115-12, K24DK002650
Study First Received: March 1, 2010
Last Updated: March 1, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014