HemoperitoneumNCT01594034
Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability and Platelet Aggregation
An observational study of Hemoperitoneum, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hemoperitoneum
- What is being tested?
- expired air
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients in the ICU on a ventilator
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemoperitoneum
- Being tested
- expired air
- Medical subject headings
- Hemoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expired airProcedure or surgery
collection of expired air from ventilator
| Study group | Role | What they receive |
|---|---|---|
| no treatment | Not described Receives: Procedure: expired air |
What is being measured
The primary outcome is the main question the study is designed to answer.
•Establish a method for reliably measuring CO excretion in patients.
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startNov 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoperitoneumStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Johnson, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594034
- Sponsor's protocol ID
- HSC-2009-0176-H
- Status last verified
- May 2012
- First submitted
- 4 May 2012
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hemoperitoneum Driven Carbon Monoxide on Post-Traumatic Stability
- ClinicalTrials.gov ID
- NCT01594034
- Acronym / sponsor ID
- HSC-2009-0176-H
- Conditions
- Hemoperitoneum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | Procedure: expired air |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in the ICU on a ventilator
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| expired aircollection of expired air from ventilator | Procedure or surgery | no treatment |
Primary outcome
•Establish a method for reliably measuring CO excretion in patients.
Time frame: 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Johnson, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoperitoneum, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
•Establish a method for reliably measuring CO excretion in patients. (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2012.