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

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ClinicalTrials.gov Identifier: NCT01594034
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : May 14, 2012
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Hemoperitoneum Procedure: expired air

Study Design
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Study Type : Observational
Actual Enrollment : 9 participants
Time Perspective: Prospective
Official Title: Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability
Study Start Date : November 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
no treatment Procedure: expired air
collection of expired air from ventilator


Outcome Measures
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Primary Outcome Measures :
  1. •Establish a method for reliably measuring CO excretion in patients. [ Time Frame: 96 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients in the ICU on a ventilator
Criteria

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.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

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