Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability and Platelet Aggregation

NCT ID: NCT01594034

Last Updated: 2012-05-14

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

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-05-31

Brief Summary

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Our objective is to determine whether or not the presence of hemoperitoneum in trauma patients is associated with increased Carbon Monoxide (CO) formation, and to determine if elevated Carbon Monoxide levels are associated with cardiovascular depression, impaired platelet aggregation, and/or multiple organ failure.

Detailed Description

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Conditions

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Hemoperitoneum

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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no treatment

expired air

Intervention Type PROCEDURE

collection of expired air from ventilator

Interventions

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expired air

collection of expired air from ventilator

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Hospitalized males 18 years of age or older,
2. Diagnosis of isolated blunt OR blunt and penetrating trauma,
3. Admitted or expecting to be admitted to the Intensive Care Unit,
4. On mechanical ventilation, and
5. Written informed consent obtained

Exclusion Criteria

1. Female gender, (Females will be excluded from this study as the menstrual cycle and other estrogen variations are known to be associated with cyclic changes in CO production adding a potential confounder to the interpretations of our findings.)
2. Diagnosis of isolated penetrating trauma,
3. Acute hemothorax or pneumothorax,
4. Treatment with antiaggregants (ASA, clopidogrel, aggrenox or ticlopidine),
5. Enrollment in another research study,
6. Prisoners,
7. Inability to perform CO measurement within 96 hours after hospital admission.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University Hospital

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-2009-0176-H

Identifier Type: -

Identifier Source: org_study_id

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