Clinical trial NCT01078324: Study of Ischemic Colitis Compared to Other Diagnoses in Patients With Lower Gastrointestinal Bleeding
Official title: Ischemic Colitis Is a Common Cause of Severe Hematochezia and Patient Outcomes Are Worse Than With Other Colonic Diagnoses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colitis, Ischemic
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-03-02
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were admitted into the hospital

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.

Eligibility 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

Primary outcomes:
measure: The clinical course and outcomes of the ischemic colitis group compared to other colonic diagnoses group
timeFrame: 12 year period
Secondary outcomes:
measure: Risk factors and prediction of ischemic colitis versus diverticulosis as the cause of severe hematochezia
timeFrame: 12 year period
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Veterans Affairs Greater Los Angeles Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Dennis M Jensen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0016-5085(88)80079-9.
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.
citation: 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. doi: 10.1056/NEJM200001133420202.