Carbon Monoxide Blood and DNA Biorepository

N/AEnrolling By InvitationNCT01758653

Intermountain Health Care, Inc.300 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Carbon Monoxide Poisoning

Interventions

No study interventionOTHER

There is no study-related intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Intermountain Medical Center

Murray, Utah, United States

LDS Hospital

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Biorepository for serum and plasma

Serum and plasma from blood collected within 24 hours of acute CO poisoning

Time frame: Within 24 hours of CO Poisoning

Secondary Outcomes

Serum and plasma (sub-acute)

Serum and plasma collected 4 weeks to 4 months after poisoning

Time frame: 4 weeks to 4 months after CO poisoning

DNA Sequestration

DNA sequestered from blood drawn up to 1 year from CO poisoning

Time frame: 24 hours to 12 months after CO poisoning

Serum and plasma (long-term)

Serum and plasma collected 4 months to 12 months after poisoning

Time frame: 4 months to 12 months after CO poisoning

Data from ClinicalTrials.gov

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