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

NCT ID: NCT01078324

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-12-31

Study Completion Date

2009-12-31

Brief Summary

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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

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

Conditions

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Colitis, Ischemic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ischemic colitis

Ischemic colitis, Diverticulosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis M Jensen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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The Veterans Affairs Greater Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 3263294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9177148 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10631275 (View on PubMed)

Other Identifiers

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K24DK002650

Identifier Type: NIH

Identifier Source: secondary_id

View Link

03-11-115-12

Identifier Type: -

Identifier Source: org_study_id

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