Carbon Monoxide Blood and DNA Biorepository

Sponsor

Intermountain Health Care, Inc. (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT01758653

Collaborator

(none)

300

Enrollment

Locations

250

Anticipated Duration (Months)

150

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Carbon Monoxide Blood and DNA Repository

Actual Study Start Date :

Feb 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2032

Anticipated Study Completion Date :

Dec 1, 2032

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Symptomatic carbon monoxide poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, loss of consciousness, etc.).
Documented exposure to carbon monoxide and no other reasonable explanation for their signs and symptoms.

Exclusion criteria:

Pregnancy
Age < 18 years
Unable to obtain informed consent
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.
Anemia requiring blood products within the last 4 months or hematocrit less than the laboratory normal reference range

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intermountain Medical Center	Murray	Utah	United States	84107
2	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lindell Weaver, Lindell Weaver, MD, Intermountain Health Care, Inc.

ClinicalTrials.gov Identifier:

NCT01758653

Other Study ID Numbers:

1024109

First Posted:

Jan 1, 2013

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Keywords provided by Lindell Weaver, Lindell Weaver, MD, Intermountain Health Care, Inc.

CO poisoning

Additional relevant MeSH terms:

Poisoning

Carbon Monoxide Poisoning

Study Results

No Results Posted as of Aug 4, 2022