Carbon Monoxide Blood and DNA Biorepository

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01758653
Recruitment Status : Enrolling by invitation
First Posted : January 1, 2013
Last Update Posted : May 4, 2018
Information provided by (Responsible Party):
Lindell Weaver, Intermountain Health Care, Inc.

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.

Condition or disease Intervention/treatment
Carbon Monoxide Poisoning Other: No study intervention

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 Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Carbon Monoxide Blood and DNA Repository
Study Start Date : February 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients with acute CO poisoning. Blood collection for biorepository only, no study intervention.
Other: No study intervention
There is no study-related intervention.

Primary Outcome Measures :
  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 Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
Blood for plasma, serum, and DNA sequestration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01758653

United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
LDS Hospital
Salt Lake City, Utah, United States, 84143
Sponsors and Collaborators
Intermountain Health Care, Inc.
Principal Investigator: Lindell K. Weaver, MD Intermountain Health Care, Inc.

Responsible Party: Lindell Weaver, Lindell Weaver, MD, Intermountain Health Care, Inc. Identifier: NCT01758653     History of Changes
Other Study ID Numbers: 1024109
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Keywords provided by Lindell Weaver, Intermountain Health Care, Inc.:
CO poisoning

Additional relevant MeSH terms:
Carbon Monoxide Poisoning
Chemically-Induced Disorders
Gas Poisoning
Carbon Monoxide
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs