Carbon Monoxide Blood and DNA Biorepository

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Lindell Weaver, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01758653
First received: December 27, 2012
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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 Intervention
Carbon Monoxide Poisoning
Other: No study intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Carbon Monoxide Blood and DNA Repository

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Biorepository for serum and plasma [ Time Frame: Within 24 hours of CO Poisoning ] [ Designated as safety issue: No ]
    Serum and plasma from blood collected within 24 hours of acute CO poisoning


Secondary Outcome Measures:
  • Serum and plasma (sub-acute) [ Time Frame: 4 weeks to 4 months after CO poisoning ] [ Designated as safety issue: No ]
    Serum and plasma collected 4 weeks to 4 months after poisoning

  • DNA Sequestration [ Time Frame: 24 hours to 12 months after CO poisoning ] [ Designated as safety issue: No ]
    DNA sequestered from blood drawn up to 1 year from CO poisoning

  • Serum and plasma (long-term) [ Time Frame: 4 months to 12 months after CO poisoning ] [ Designated as safety issue: No ]
    Serum and plasma collected 4 months to 12 months after poisoning


Biospecimen Retention:   Samples With DNA

Blood for plasma, serum, and DNA sequestration


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Biorepository
Patients with acute CO poisoning. Blood collection for biorepository only, no study intervention.
Other: No study intervention
There is no study-related 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758653

Locations
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.
Investigators
Principal Investigator: Lindell K. Weaver, MD Intermountain Health Care, Inc.
  More Information

No publications provided

Responsible Party: Lindell Weaver, Lindell Weaver, MD, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01758653     History of Changes
Other Study ID Numbers: 1024109
Study First Received: December 27, 2012
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 30, 2014