Carbon Monoxide Blood and DNA Biorepository
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No study intervention.
- Who it may be relevant to
- Registry conditions: Carbon Monoxide Poisoning. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Carbon Monoxide Blood and DNA Repository
Overview
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.
Interventions
- Other No study intervention
There is no study-related intervention.
Primary outcome measures
- Biorepository for serum and plasma [Time frame: Within 24 hours of CO Poisoning]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Intermountain Medical Center — Murray
- LDS Hospital — Salt Lake City
Identifiers
NCT: NCT01758653 · 1024109