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

Completed

• Conditions: Colitis, Ischemic

• Registration Number: NCT01078324
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 1997-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The clinical course and outcomes of the ischemic colitis group compared to other colonic diagnoses group	12 year period

Secondary Outcome Measures

Name	Time	Method
Risk factors and prediction of ischemic colitis versus diverticulosis as the cause of severe hematochezia	12 year period

Trial Locations

Locations (1)

The Veterans Affairs Greater Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States