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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01078324

Enrollment

550

Registered

2010-03-02

Start date

1997-12-31

Completion date

2009-12-31

Last updated

2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ischemic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results