Carbon Monoxide Blood and DNA Biorepository

Carbon Monoxide Blood and DNA Repository

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Carbon Monoxide Poisoning
• Intervention / Treatment: 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
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biorepository for serum and plasma	Serum and plasma from blood collected within 24 hours of acute CO poisoning	Within 24 hours of CO Poisoning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum and plasma (sub-acute)	Serum and plasma collected 4 weeks to 4 months after poisoning	4 weeks to 4 months after CO poisoning
DNA Sequestration	DNA sequestered from blood drawn up to 1 year from CO poisoning	24 hours to 12 months after CO poisoning
Serum and plasma (long-term)	Serum and plasma collected 4 months to 12 months after poisoning	4 months to 12 months after CO poisoning

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Lindell K. Weaver, MD, Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: December 27, 2012
• First Submitted That Met QC Criteria: December 27, 2012
• First Posted (Estimated): January 1, 2013

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: CO poisoning
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Gas Poisoning; Poisoning; Carbon Monoxide Poisoning
• Other Study ID Numbers: 1024109