Clinical trial NCT01758653: Carbon Monoxide Blood and DNA Biorepository
Official title: Carbon Monoxide Blood and DNA Repository
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Carbon Monoxide Poisoning
Keywords: CO poisoning
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Symptomatic carbon monoxide poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, loss of consciousness, etc.).
2. Documented exposure to carbon monoxide and no other reasonable explanation for their signs and symptoms.

Exclusion criteria:

1. Pregnancy
2. Age \< 18 years
3. Unable to obtain informed consent
4. 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.
5. Anemia requiring blood products within the last 4 months or hematocrit less than the laboratory normal reference range

Primary outcomes:
measure: Biorepository for serum and plasma
timeFrame: Within 24 hours of CO Poisoning
Secondary outcomes:
measure: Serum and plasma (sub-acute)
timeFrame: 4 weeks to 4 months after CO poisoning
measure: DNA Sequestration
timeFrame: 24 hours to 12 months after CO poisoning
measure: Serum and plasma (long-term)
timeFrame: 4 months to 12 months after CO poisoning
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Lindell K. Weaver, MD
role: PRINCIPAL_INVESTIGATOR
References: