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Enrolling by Invitation

NCT Number: NCT01758653

Carbon Monoxide Blood and DNA Biorepository

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Medical Center, Murray, Utah, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No study intervention

Other

There is no study-related intervention.

Primary outcomes

  1. 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

Secondary outcomes

  1. Serum and plasma (sub-acute)

    Time frame: 4 weeks to 4 months after CO poisoning

    Serum and plasma collected 4 weeks to 4 months after poisoning

  2. DNA Sequestration

    Time frame: 24 hours to 12 months after CO poisoning

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

  3. Serum and plasma (long-term)

    Time frame: 4 months to 12 months after CO poisoning

    Serum and plasma collected 4 months to 12 months after poisoning

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Official study title

Carbon Monoxide Blood and DNA Repository

Important dates

Study start
2012
Primary completion
2032
Study completion
2032
First posted
Jan 1, 2013
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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