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

Completed

• Conditions: Hemoperitoneum
• Interventions: Procedure: expired air

• Registration Number: NCT01594034
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-05
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Last Update Submitted: 2012-05-11
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no treatment	expired air	-

Primary Outcome Measures

Name	Time	Method
•Establish a method for reliably measuring CO excretion in patients.	96 hours

Trial Locations

Locations (1)

University Hospital; 🇺🇸 San Antonio, Texas, United States