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
  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
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:

  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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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

No publications provided

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
Pharmacologic Actions
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014