Carbon Monoxide Blood and DNA Biorepository

• Conditions: Carbon Monoxide Poisoning
• Interventions: Other: No study intervention

• Registration Number: NCT01758653
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-12-27
• Study First Submitted QC: 2012-12-27
• Study First Posted: 2013-01-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29
• Primary Completion: 2032-12
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biorepository	No study intervention	Patients with acute CO poisoning. Blood collection for biorepository only, no study intervention.

Primary Outcome Measures

Name	Time	Method
Biorepository for serum and plasma	Within 24 hours of CO Poisoning	Serum and plasma from blood collected within 24 hours of acute CO poisoning

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States