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

NCT01594034 | Completed

• 1 other identifier: HSC-2009-0176-H
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemoperitoneum

Outcome Measures

Primary Outcomes (1)

• •Establish a method for reliably measuring CO excretion in patients.

  96 hours

Study Arms (1)

no treatment

Procedure: expired air

Interventions

expired air PROCEDURE

collection of expired air from ventilator

no treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients in the ICU on a ventilator

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Hemoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Johnson, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 8, 2012
• Study Start: November 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 14, 2012

Record last verified: 2012-05

Locations

US (1)