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

Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability

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.

Study Overview

• Status: Completed
• Conditions: Hemoperitoneum
• Intervention / Treatment: Procedure: expired air

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

patients in the ICU on a ventilator

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
•Establish a method for reliably measuring CO excretion in patients.	96 hours

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Robert Johnson, PhD, University of Texas

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Estimate): May 14, 2012
• Last Update Submitted That Met QC Criteria: May 11, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Peritoneal Diseases; Hemorrhage; Hemoperitoneum
• Other Study ID Numbers: HSC-2009-0176-H