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

This study has been completed.

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

Tracking Information

First Received Date ^ICMJE

March 1, 2010

Last Updated Date

March 1, 2010

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

The clinical course and outcomes of the ischemic colitis group compared to other colonic diagnoses group [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients who were admitted into the hospital

Condition ^ICMJE

Colitis, Ischemic

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Ischemic colitis

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

550

Completion Date

December 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01078324

Other Study ID Numbers ^ICMJE

03-11-115-12, K24DK002650

Has Data Monitoring Committee

Responsible Party

Dennis Jensen, M.D., University of California, Los Angeles

Study Sponsor ^ICMJE

University of California, Los Angeles

Collaborators ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators ^ICMJE

Principal Investigator:

Dennis M Jensen, M.D.

University of California, Los Angeles

Information Provided By

University of California, Los Angeles

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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