NCT01758653

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
80mo left

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Feb 2012Dec 2032

Study Start

First participant enrolled

February 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
19.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

20.8 years

First QC Date

December 27, 2012

Last Update Submit

September 27, 2023

Conditions

Keywords

CO poisoning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Serum and plasma (sub-acute)

    4 weeks to 4 months after CO poisoning

  • DNA Sequestration

    24 hours to 12 months after CO poisoning

  • Serum and plasma (long-term)

    4 months to 12 months after CO poisoning

Study Arms (1)

Biorepository

Patients with acute CO poisoning. Blood collection for biorepository only, no study intervention.

Other: No study intervention

Interventions

There is no study-related intervention.

Biorepository

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood for plasma, serum, and DNA sequestration

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Lindell K. Weaver, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lindell Weaver, MD

Study Record Dates

First Submitted

December 27, 2012

First Posted

January 1, 2013

Study Start

February 1, 2012

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations