Carbon Monoxide PoisoningNCT01758653
Carbon Monoxide Blood and DNA Biorepository
An observational study of Carbon Monoxide Poisoning, run by Intermountain Health Care, Inc. at 2 sites in United States.
Trial summary
The purpose of this biorepository is to collect blood from patients at the time of CO poisoning and at follow-up visits months to years later. These samples can be used in the future to learn more about how CO damages the heart and brain and whether blood tests could predict which patients will have problems after CO… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- No study intervention
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population includes patients who present to LDS Hospital or Intermountain Medical Center with symptomatic carbon monoxide poisoning and documented exposure to carbon monoxide.
Who may be able to join
- Symptomatic carbon monoxide poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, loss of consciousness, etc.).
- Documented exposure to carbon monoxide and no other reasonable explanation for their signs and symptoms.
Who cannot join
- Pregnancy
- Age < 18 years
- Unable to obtain informed consent
- Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason. The investigator and the Sponsor, prior to enrolling the subject on a case-by-case basis, must approve and document any waiver of these inclusion and exclusion criteria.
- Anemia requiring blood products within the last 4 months or hematocrit less than the laboratory normal reference range
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Intermountain Medical Center
Murray, Utah, 84107
LDS Hospital
Salt Lake City, Utah, 84143
About this study
Official title: Carbon Monoxide Blood and DNA Repository
The purpose of this biorepository is to collect blood from patients at the time of CO poisoning and at follow-up visits months to years later. These samples can be used in the future to learn more about how CO damages the heart and brain and whether blood tests could predict which patients will have problems after CO poisoning.
Read the detailed description
The investigators propose to establish a biorepository for storage of serum, plasma, and DNA collected from patients with carbon monoxide (CO) poisoning. Participants will also be evaluated for clinical outcome. The biorepository will include serum and plasma from CO-poisoned patients drawn at the time of injury as well as from blood drawn at clinical follow-up visits. The biorepository will also bank DNA from these participants.
These specimens can be analyzed in the future to elucidate potential inflammatory and immunological mechanisms that cause brain and heart damage and identify possible biological and genetic predictors of poor outcome.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- No study intervention
- Keywords
- CO poisoning
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study interventionOther
There is no study-related intervention.
| Study group | Role | What they receive |
|---|---|---|
| Biorepository | Patients with acute CO poisoning. Blood collection for biorepository only, no study intervention. Receives: Other: No study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biorepository for serum and plasma
Serum and plasma from blood collected within 24 hours of acute CO poisoning
Measured: Within 24 hours of CO Poisoning
Secondary outcomes (3)
Serum and plasma (sub-acute)
Serum and plasma collected 4 weeks to 4 months after poisoning
Measured: 4 weeks to 4 months after CO poisoning
DNA Sequestration
DNA sequestered from blood drawn up to 1 year from CO poisoning
Measured: 24 hours to 12 months after CO poisoning
Serum and plasma (long-term)
Serum and plasma collected 4 months to 12 months after poisoning
Measured: 4 months to 12 months after CO poisoning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindell Weaver, Intermountain Health Care, Inc.
- Investigators
- Lindell K. Weaver, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758653
- Sponsor's protocol ID
- 1024109
- Status last verified
- Sep 2023
- First submitted
- 27 Dec 2012
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon Monoxide Blood and DNA Repository
- ClinicalTrials.gov ID
- NCT01758653
- Acronym / sponsor ID
- 1024109
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- CO poisoning
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 1 Jan 2013 (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.
The purpose of this biorepository is to collect blood from patients at the time of CO poisoning and at follow-up visits months to years later. These samples can be used in the future to learn more about how CO damages the heart and brain and whether blood tests could predict which patients will have problems after CO poisoning.
Detailed description
The investigators propose to establish a biorepository for storage of serum, plasma, and DNA collected from patients with carbon monoxide (CO) poisoning. Participants will also be evaluated for clinical outcome. The biorepository will include serum and plasma from CO-poisoned patients drawn at the time of injury as well as from blood drawn at clinical follow-up visits. The biorepository will also bank DNA from these participants.
These specimens can be analyzed in the future to elucidate potential inflammatory and immunological mechanisms that cause brain and heart damage and identify possible biological and genetic predictors of poor outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biorepository | – | Other: No study interventionPatients with acute CO poisoning. Blood collection for biorepository only, no study intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes patients who present to LDS Hospital or Intermountain Medical Center with symptomatic carbon monoxide poisoning and documented exposure to carbon monoxide.
Key inclusion criteria (2 listed)
- Symptomatic carbon monoxide poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, loss of consciousness, etc.).
- Documented exposure to carbon monoxide and no other reasonable explanation for their signs and symptoms.
Key exclusion criteria (5 listed)
- Pregnancy
- Age < 18 years
- Unable to obtain informed consent
- Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason. The investigator and the Sponsor, prior to enrolling the subject on a case-by-case basis, must approve and document any waiver of these inclusion and exclusion criteria.
- Anemia requiring blood products within the last 4 months or hematocrit less than the laboratory normal reference range
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 |
|---|---|---|
| No study interventionThere is no study-related intervention. | Other | Biorepository |
Primary outcome
Biorepository for serum and plasma
Time frame: Within 24 hours of CO Poisoning
Serum and plasma from blood collected within 24 hours of acute CO poisoning
3 secondary outcomes
Serum and plasma (sub-acute)
Time frame: 4 weeks to 4 months after CO poisoning
DNA Sequestration
Time frame: 24 hours to 12 months after CO poisoning
Serum and plasma (long-term)
Time frame: 4 months to 12 months after CO poisoning
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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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.
Lindell K. Weaver, MD principal investigator
Intermountain Health Care, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide Poisoning, run by Intermountain Health Care, Inc. at 2 sites 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 2 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Biorepository for serum and plasma (time frame: Within 24 hours of CO Poisoning). 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 29 Sep 2023.