Carbon Monoxide Blood and DNA Biorepository

Study Overview
=================
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.

Official Title
-----------------
Carbon Monoxide Blood and DNA Repository

Conditions
-----------------
Carbon Monoxide Poisoning

Intervention / Treatment
-----------------
* Other: No study intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biorepository<br>Patients with acute CO poisoning. Blood collection for biorepository only, no study intervention. | Other: No study intervention<br>* There is no study-related intervention.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CO poisoning