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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

Tracking Information
First Submitted Date May 4, 2012
First Posted Date May 8, 2012
Last Update Posted Date May 14, 2012
Study Start Date November 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2012)
•Establish a method for reliably measuring CO excretion in patients. [ Time Frame: 96 hours ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability and Platelet Aggregation
Official Title Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability
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 Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients in the ICU on a ventilator
Condition Hemoperitoneum
Intervention Procedure: expired air
collection of expired air from ventilator
Study Groups/Cohorts no treatment
Intervention: Procedure: expired air
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 7, 2012)
9
Original Actual Enrollment Same as current
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01594034
Other Study ID Numbers HSC-2009-0176-H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor The University of Texas Health Science Center at San Antonio
Collaborators Not Provided
Investigators
Principal Investigator: Robert Johnson, PhD University of Texas
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date May 2012