Carbon Monoxide Blood and DNA Biorepository

Carbon Monoxide Poisoning Clinical Trial

Official title:

Carbon Monoxide Blood and DNA Repository

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01758653
• Other study ID #: 1024109
• Status: Enrolling by invitation
• Start date: February 2012
• Est. completion date: December 2032

Study information

• Verified date: September 2023
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 2032
• Est. primary completion date: December 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carbon Monoxide Poisoning
• Poisoning

Intervention

Other:
• No study intervention
There is no study-related intervention.

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah
United States	LDS Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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