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

NCT01078324 | Completed

• 2 other identifiers: 03-11-115-12K24DK002650
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis, Ischemic

Outcome Measures

Primary Outcomes (1)

• The clinical course and outcomes of the ischemic colitis group compared to other colonic diagnoses group

  12 year period

Secondary Outcomes (1)

• Risk factors and prediction of ischemic colitis versus diverticulosis as the cause of severe hematochezia

  12 year period

Study Arms (1)

Ischemic colitis

Ischemic colitis, Diverticulosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who were admitted into the hospital

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The Veterans Affairs Greater Los Angeles Medical Center

Los Angeles, California, 90073, United States

Location

Related Publications (3)

• 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.

  PMID: 3263294 BACKGROUND

• 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.

  PMID: 9177148 BACKGROUND

• 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.

  PMID: 10631275 BACKGROUND

MeSH Terms

Conditions

Colitis, Ischemic

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dennis M Jensen, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: December 1, 1997
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 19, 2016

Record last verified: 2016-08

Locations

US (1)