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

Colitis, Ischemic Clinical Trial

Official title:

Ischemic Colitis Is a Common Cause of Severe Hematochezia and Patient Outcomes Are Worse Than With Other Colonic Diagnoses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078324
• Other study ID #: 03-11-115-12
• Secondary ID: K24DK002650
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: August 17, 2016
• Start date: December 1997
• Est. completion date: December 2009

Study information

• Verified date: August 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ischemic
• Ischemia

Locations

Country	Name	City	State
United States	The Veterans Affairs Greater Los Angeles Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Jensen DM, Machicado GA, Jutabha R, Kovacs TO. Urgent colonoscopy for the diagnosis and treatment of severe diverticular hemorrhage. N Engl J Med. 2000 Jan 13;342(2):78-82. — View Citation

Jensen DM, Machicado GA. Colonoscopy for diagnosis and treatment of severe lower gastrointestinal bleeding. Routine outcomes and cost analysis. Gastrointest Endosc Clin N Am. 1997 Jul;7(3):477-98. Review. — View Citation

Jensen DM, Machicado GA. Diagnosis and treatment of severe hematochezia. The role of urgent colonoscopy after purge. Gastroenterology. 1988 Dec;95(6):1569-74. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinical course and outcomes of the ischemic colitis group compared to other colonic diagnoses group		12 year period	No
Secondary	Risk factors and prediction of ischemic colitis versus diverticulosis as the cause of severe hematochezia		12 year period	No