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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT01594034

First received: May 4, 2012

Last updated: May 11, 2012

Last verified: May 2012

History of Changes

Purpose

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.

Condition	Intervention
Hemoperitoneum	Procedure: expired air


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

•Establish a method for reliably measuring CO excretion in patients. [ Time Frame: 96 hours ] [ Designated as safety issue: No ]


Enrollment:	9
Study Start Date:	November 2009
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
no treatment	Procedure: expired air collection of expired air from ventilator

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

patients in the ICU on a ventilator

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.)
Diagnosis of isolated penetrating trauma,
Acute hemothorax or pneumothorax,
Treatment with antiaggregants (ASA, clopidogrel, aggrenox or ticlopidine),
Enrollment in another research study,
Prisoners,
Inability to perform CO measurement within 96 hours after hospital admission.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01594034

Locations


United States, Texas
University Hospital
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators


Principal Investigator:	Robert Johnson, PhD	University of Texas

More Information


Responsible Party:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT01594034 History of Changes
Other Study ID Numbers:	HSC-2009-0176-H
Study First Received:	May 4, 2012
Last Updated:	May 11, 2012
Health Authority:	United States: Institutional Review Board United States: Federal Government

Additional relevant MeSH terms:


Hemoperitoneum Peritoneal Diseases Digestive System Diseases Hemorrhage Pathologic Processes Carbon Monoxide	Antimetabolites Molecular Mechanisms of Pharmacological Action Gasotransmitters Neurotransmitter Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016

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